An Indian surgeon's perspective on management of asymptomatic gallstones.

INTRODUCTION: Cholelithiasis is widely prevalent in India, with a majority of patients being asymptomatic while a small proportion experiencing mild complications. In the laparoscopic era, the rate of cholecystectomies has increased owing to early recovery and fewer complications. In asymptomatic patients, the risk of complications must be balanced against the treatment benefit. Recent guidelines suggest no prophylactic cholecystectomy in asymptomatic patients. We aimed to find out the Indian surgeons' perspective on asymptomatic gallstone management. METHODS: A cross-sectional e-survey was conducted of practicing surgeons, onco-surgeons and gastrointestinal-surgeons in India. The survey had questions regarding their perspective on laparoscopic cholecystectomy and treatment modalities in asymptomatic gallstones. RESULTS: A total of 196 surgeons responded to the survey. Their mean age was 42.3 years. Overall, 111 (57%) respondents worked in the private sector. Most surgeons (164) agreed that the rate of cholecystectomy has increased since the advent of laparoscopy; 137 (70%) respondents agreed that they would not operate on patients without risk factors. Common bile duct stones, chronic hemolytic diseases, transplant recipients, and diabetes mellitus were the risk factors. Majority of the participants agreed on not performing a cholecystectomy in patients with asymptomatic gallstones. CONCLUSION: There exists a lack of consensus among Indian surgeons on asymptomatic gallstone management in India. Where the majority of cases are asymptomatic and do not require surgery, certain comorbidities can influence the line of treatment in individual patients. Currently, the treatment guidelines for asymptomatic patients need to be established as cholecystectomies may be overperformed due to the fear of development of complications.

Does women empowerment associate with reduced risks of intimate partner violence in India? evidence from National Family Health Survey-5.

BACKGROUND: Women empowerment is commonly believed to be an important factor affecting a woman's likelihood of facing violence from her intimate partner. Even as countries invest in policies that aim to strengthen women empowerment, studies show that increase in women empowerment does not necessarily decrease intimate partner violence (IPV) against them. Against this paradox, the present study seeks to understand the specific empowerment components that associate with IPV against women in India. It also studies the state-level distribution of the different types of IPV. METHODS: The study analyses state-level data from the National Family Health Survey, India (2019-21). A total of 72,056 women responded to the domestic violence questionnaire. The Dimension Index (DI) was used to compute composite scores for Women Empowerment and for IPV to rank states and Union Territories. The correlation between Women Empowerment and IPV scores was determined using Spearman's rank correlation coefficient. RESULTS: The state of Karnataka had the highest composite score of IPV and also showed the highest burdens of physical, sexual and emotional IPV, while Lakshadweep had the lowest burden. Physical IPV was the most common form of IPV for most states across the country. The states in the western part of India had reduced burdens for all three types of IPV. Three specific components of empowerment, viz. household decision-making and mobile phone ownership significantly associated with reduction of all three types of IPV. Hygienic menstrual practices strongly associated with reduction of sexual and emotional IPV. However, property ownership of women increased risks of all three types of IPV, while employment had no significant association with any type of IPV. CONCLUSIONS: The study found no significant reduction in overall IPV with improvement in women empowerment. However, it identifies components of empowerment that associate with IPV. Household decision-making, ownership of mobile phones, and hygienic menstrual practices associated with a lowered risk. By contrast, owning property increased the risk. The findings of this study would inform future research and intervention that aim to strengthen specific components of women empowerment in India and other low-and-middle-income countries.

Connectivity and Integration of Instagram® Use in the Lives of Dental Students and Professionals: A Country-Wide Cross-Sectional Study Using the InstaAA© Questionnaire.

Purpose: This study probed towards the impact of Instagram® on the lives of dental students and professionals and how it affects their learning and professional performance. Patients and Methods: A 24-item copyrighted and validated questionnaire was employed to examine the affinity and aftermath of Instagram® in the lives of dental students using a cross-sectional survey technique. Part I (6 questions) is the first of three sections included information on the participant's sociodemographic traits, Part II (8 questions) - Screened to determine Instagram® use, and Part III (10 questions) - Was based on attitudes regarding Instagram® to assess their mental, physical, and emotional well-being. It includes a Likert scale with ten questions. The sample was collected by combining convenience and snowball sampling approaches. The difference in proportion was assessed using frequency and percentage. The Chi Square test of proportion was used to the data to examine and a p value <0.05 was considered as the proportional difference. Results: The study comprised 461 participants, with 155 (33.6%) men and 306 (66.4%) women, having an average age of 23.13 ± 4.95 years. Among the participants, a significant proportion (119, 25.8%) were dental interns. In terms of Instagram® usage, 167 participants (36.2%) reported spending between 30 minutes and 1 hour on the platform (p<0.01). Approximately 52.5% acknowledged the influence of Instagram® on their dressing, behaviour, and usage of other social media platforms (p<0.01). Moreover, 52.1% experienced common distractions while performing important tasks, and 40.6% reported negative effects on their mental and emotional well-being (p<0.05). Conclusion: This research concludes by emphasizing the huge influence that Instagram® has on dental workers' life. The results underline the necessity of striking a balance between social media use and academic and personal obligations while also emphasizing the need for knowledge and education about Instagram® features and ramifications.

Recognising socio-cultural barriers while seeking early detection services for breast cancer: a study from a Universal Health Coverage setting in India.

BACKGROUND: Breast cancer is the commonest cancer among women in India, yet the uptake of early detection programs is poor. This leads to late presentation, advanced stage at the time of diagnosis, and high mortality. Poor accessibility and affordability are the most commonly cited barriers to screening: we analyse socio-cultural factors influencing the uptake of early detection programmes in a Universal Health Coverage (UHC) setting in India, where geographical and financial barriers were mitigated. METHODS: Two hundred seventy-two women engaging in an awareness-based early detection program were recruited by randomization as the participant (P) group. A further 272 women who did not participate in the early detection programme were recruited as non-participants (NP). None of the groups were previously screened for breast cancer. Interviews were conducted using a 19-point questionnaire, consisting of closed-ended questions regarding demographics and social, cultural, spiritual and trust-related barriers. RESULTS: The overall awareness about breast cancer was high among both groups. None of the groups reported accessibility-related barriers. Participants were more educated (58.09% vs 47.43%, p = 0.02) and belonged to nuclear families (83.59% vs 76.75%, p = 0.05). Although they reported more fear of isolation due to stigma (25% vs 14%, p = 0.001), they had greater knowledge about breast cancer and trust in the health system compared to non-participants. CONCLUSIONS: The major socio-cultural barriers identified were joint family setups, lower education and awareness, and lack of trust in healthcare professionals. As more countries progress towards UHC, recognising socio-cultural barriers to seeking breast health services is essential in order to formulate context-specific solutions to increase the uptake of early detection and screening services.

Concerns and coping mechanisms of breast cancer survivor women from Asia: a scoping review.

PURPOSE: The incidence of breast cancer has increased significantly in Asia due to epidemiological transition and changes in human development indices. Advancement in medical technology has improved prognosis with a resultant increase in survivorship issues. The effects of breast cancer diagnosis and treatment are influenced by the patient's cultural beliefs and social systems. This scoping review aims to summarise concerns and coping mechanisms of women with breast cancer in Asia and understand gaps in the existing literature. METHODS: We performed a scoping review using the population-concept-context strategy. A systematic search of MEDLINE (PubMed, Web of Science), CINAHL, SCOPUS, and Embase was conducted for studies conducted in Asia on women diagnosed with breast cancer, identifying their concerns and coping mechanisms, published between January 2011 and January 2021. Data from included studies were reported using frequencies and percentages. RESULTS: We included 163 studies, of which most (81%) were conducted in hospital settings. Emotional and psychological concerns were reported in 80% of studies, followed by physical appearance and body-image concerns in 46%. Social support (59%), emotion-based coping (46%), spirituality, and problem-based coping (37%) were the major coping systems documented. CONCLUSION: The mapped literature documented that anxiety, depression, and fear of cancer recurrence dominated women's emotional concerns. Women coped with the help of social support, positive reappraisal, and faith in God and religion. Sensitization of caregivers, including healthcare professionals and family members, to context-specific concerns and inquiry into the patients' available support systems is essential in strengthening breast cancer women's recovery and coping.

Are LMICs Achieving the Lancet Commission Global Benchmark for Surgical Volumes? A Systematic Review.

INTRODUCTION: The Lancet Commission on Global Surgery (LCoGS) set the benchmark of 5000 procedures per 100,000 population annually to meet surgical needs adequately. This systematic review provides an overview of the last ten years of surgical volumes in Low and Middle- Income-Countries (LMICs). METHODOLOGY: We searched PubMed, Web of Science, Scopus, Cochrane, and EMBASE databases for studies from LMICs addressing surgical volume. The number of surgeries performed per 100,000 population was estimated. We used cesarean sections, hernia, and laparotomies as index cases for the surgical capacities of the country. Their proportions to total surgical volumes were estimated. The association of country-specific surgical volumes and the proportion of index cases with its Gross Domestic Product (GDP) per capita was analyzed. RESULTS: A total of 26 articles were included in this review. In LMICs, on average, 877 surgeries were performed per 100,000 population. The proportion of cesarean sections was found to be high in all LMICs, with an average of 30.1% of the total surgeries, followed by hernia (16.4%) and laparotomy (5.1%). The overall surgical volumes increased as the GDP per capita increased. The proportions of cesarean section and hernia to total surgical volumes decreased with increased GDP per capita. Significant heterogeneity was found in the methodologies to assess surgical volumes, and inconsistent reporting hindered comparison between countries. CONCLUSION: Most LMICs have surgical volumes below the LCoGS benchmark of 5000 procedures per 100,000 population, with an average of 877 surgeries. The surgical volume increased while the proportions of hernia and cesarean sections reduced with increased GDP per capita. In the future, it's essential to apply uniform and reproducible data collection methods for obtaining multinational data that can be more accurately compared.

Geographic and socioeconomic inequities in cesarean delivery rates at the district level in Madhya Pradesh, India: A secondary analysis of the national family health survey-5.

BACKGROUND: In India, caesarean delivery (CD) accounts for 17% of the births, of which 41% occur in private facilities. However, areas to CD in rural areas are limited, particularly for the poor populations. Little information is available on state-wise district-level CD rates by geography and the population wealth quintiles, especially in Madhya Pradesh (MP), the fifth most populous and third poorest state. OBJECTIVE: Investigate geographic and socioeconomic inequities of CD across the 51 districts in MP and compare the contribution of public and private healthcare facilities to the overall state CD rate. METHODS: This cross-sectional study utilised the summary fact sheets of the National Family Health Survey (NFHS)-5 performed from January 2019 to April 2021. Women aged 15 to 49 years, with live births two years preceding the survey were included. District-level CD rates in MP were used to determine the inequalities in accessing CD in the poorer and poorest wealth quintiles. CD rates were stratified as <10%, 10-20% and >20% to measure equity of access. A linear regression model was used to examine the correlation between the fractions of the population in the two bottom wealth quintiles and CD rates. RESULTS: Eighteen districts had a CD rate below 10%, 32 districts were within the 10%-20% threshold and four had a rate of 20% or higher. Districts with a higher proportion of poorer population and were at a distance from the capital city Bhopal were associated with lower CD rates. However, this decline was steeper for private healthcare facilities (R2 = 0.382) revealing a possible dependency of the poor populations on public healthcare facilities (R2 = 0.009) for accessing CD. CONCLUSION: Although CD rates have increased across MP, inequities within districts and wealth quintiles exist, warranting closer attention to the outreach of government policies and the need to incentivise CDs where underuse is significant.

Breast Conservative Surgery for Breast Cancer: Indian Surgeon's Preferences and Factors Influencing Them.

Background: It is well established that disease-free survival and overall survival after breast conservation surgery (BCS) followed by radiotherapy are equivalent to that after mastectomy. However, in Asian countries, the rate of BCS continues to remain low. The cause may be multifactorial including the patient's choice, availability and accessibility of infrastructure, and surgeon's choice. We aimed to elucidate the Indian surgeons' perspective while choosing between BCS and mastectomy, in women oncologically eligible for BCS. Methods: We conducted a survey-based cross-sectional study in January-February 2021. Indian surgeons with general surgical or specialised oncosurgical training, who consented to participate were included in the study. Multinomial logistic regression was performed to assess the effect of study variables on offering mastectomy or BCS. Results: A total of 347 responses were included. The mean age of the participants was 43 ± 11 years. Sixty-three of the surgeons were in the 25-44 years age group with the majority (80%) being males. 66.4% of surgeons 'almost always' offered BCS to oncologically eligible patients. Surgeons who had undergone specialised training in oncosurgery or breast conservation surgery were 35 times more likely to offer BCS (p < 0.01). Surgeons working in hospitals with in-house radiation oncology facilities were 9 times more likely to offer BCS (p < 0.05). Surgeons' years of practice, age, sex and hospital setting did not influence the surgery offered. Conclusion: Two-thirds of Indian surgeons preferred BCS over mastectomy. Lack of radiotherapy facilities and specialised surgical training were deterrents to offering BCS to eligible women. Supplementary Information: The online version contains supplementary material available at 10.1007/s13193-022-01601-y.

Does women's empowerment and their socioeconomic condition affect the uptake of breast cancer screening? Findings from NFHS-5, India.

BACKGROUND: Screening for breast cancer results in early diagnosis of the disease and improves survival. However, increasing participation of women in screening programs is challenging since it is influenced by socioeconomic and cultural factors. This study explores the relationship of socioeconomic and women empowerment factors with breast cancer screening uptakes in the states and union territories of India. METHODS: We used summary reports of secondary data from all the states and union territories based on the fifth wave of the National Family Health Survey in India. This ecological study compares the uptake of breast cancer screening across states of India. We considered socioeconomic status (SES) and women empowerment status (WES) indicators from the survey as independent variables and state-wise breast cancer screening uptake as dependent variables for studying their association. The determinants of breast cancer screening were calculated using a simple linear regression model. RESULTS: We found that socioeconomic status and women empowerment status moderately correlated with breast cancer screening uptake (correlation coefficient 0.34 and 0.38, respectively). States with higher rates of literacy among women and of women who had their own bank accounts that they decided how to use reported higher uptake of breast cancer screening (p = 0.01 and 0.03, respectively). However, the correlation was not uniform across all the states. The states of Chandigarh, Delhi, Telangana, and Karnataka showed lower participation despite a higher percentage of literate women and women with their own bank accounts. CONCLUSION: This study indicates that women's literacy and having their own bank account may moderately improve their participation in cancer screening. However, higher SES and WES did not translate into better screening in many of the states. More research is needed, especially for states which had low screening uptake despite relatively higher rates of women empowerment.

Mortality and Risk Factors in Isolated Traumatic Brain Injury Patients: A Prospective Cohort Study.

INTRODUCTION: Outcomes in patients with isolated traumatic brain injury (iTBI) have not been evaluated comprehensively in low-income and middle-income countries. We aimed to study the in-hospital iTBI mortality and its associated risk factors in a prospective multicenter Indian trauma registry. METHODS: Patients with iTBI (head and neck Abbreviated Injury Score ≥2 and other region Abbreviated Injury Score ≤2) were included. Study variables comprised age, gender, mechanism of injury, systolic blood pressure (SBP) at arrival, Glasgow Coma Scale (GCS) score - classified as mild (13-15), moderate (9-12), and severe (3-8), transfer status, and time to presentation at any participating hospital. A multivariable logistic regression was performed to assess the impact of these factors on 24-h and 30-d mortality following iTBI. RESULTS: Among 5042 included patients, 24-h and 30-d in-hospital mortalities were 5.9% and 22.4%. On a regression analysis, 30-d mortality was associated with age ≥45 y (odds ratio [OR] = 2.1 [1.6-2.7]), railway injury mechanisms (OR = 2.1 [1.3-3.5]), SBP <90 mmHg (OR = 2.6 [1.6-4.1]), and moderate (OR = 3.8 [3.0-5.0]) to severe (OR = 21.1 [16.8-26.7]) iTBI based on GCS scores. 24-h mortality showed similar trends. Patients transferred to the participating hospitals from other centers had higher odds of 30-d mortality (OR = 1.4 [1.2-1.8]) compared to those arriving directly. Those who received neurosurgical intervention had lower odds of 24-h mortality (0.3 [0.2-0.4]). CONCLUSIONS: Age ≥45 y, GCS score ≤12, and SBP <90 mmHg at arrival increased the risk of in-hospital mortality from iTBI.

A pilot multicentre cluster randomised trial to compare the effect of trauma life support training programmes on patient and provider outcomes.

INTRODUCTION: Trauma accounts for nearly 10% of the global burden of disease. Several trauma life support programmes aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programmes on patient outcomes. We describe the protocol of a pilot study that aims to assess the feasibility of conducting a cluster randomised controlled trial comparing advanced trauma life support (ATLS) and primary trauma care (PTC) with standard care. METHODS AND ANALYSIS: We will pilot a pragmatic three-armed parallel, cluster randomised controlled trial in India, where neither of these programmes are routinely taught. We will recruit tertiary hospitals and include trauma patients and residents managing these patients. Two hospitals will be randomised to ATLS, two to PTC and two to standard care. The primary outcome will be all-cause mortality at 30 days from the time of arrival to the emergency department. Our secondary outcomes will include patient, provider and process measures. All outcomes except time-to-event outcomes will be measured both as final values as well as change from baseline. We will compare outcomes in three combinations of trial arms: ATLS versus PTC, ATLS versus standard care and PTC versus standard care using absolute and relative differences along with associated CIs. We will conduct subgroup analyses across the clinical subgroups men, women, blunt multisystem trauma, penetrating trauma, shock, severe traumatic brain injury and elderly. In parallel to the pilot study, we will conduct community consultations to inform the planning of the full-scale trial. ETHICS AND DISSEMINATION: We will apply for ethics approvals to the local institutional review board in each hospital. The protocol will be published to Clinical Trials Registry-India and ClinicalTrials.gov. The results will be published and the anonymised data and code for analysis will be released publicly.

Assessing the Rates and Reasons of Elective Surgical Cancellations on the Day of Surgery: A Multicentre Study from Urban Indian Hospitals.

BACKGROUND: Cancellations of elective surgeries on the day of surgery (DOS) can lead to added financial burden and wastage of resources for healthcare facilities; as well as social and emotional problems to patients. These cancellations act as barriers to delivering efficient surgical services. Optimal utilisation of the available resources is necessary for resource-constrained low-and-middle-income countries (LMIC). This study investigates the rate and causes of cancellations of elective surgeries on the DOS in various surgical departments across ten hospitals in India. METHODS: A research consortium 'IndSurg' led by World Health Organisation Collaboration Centre (WHOCC) for Research in Surgical Care Delivery in LMICs, India conducted this multicentre retrospective cross-sectional study to analyse the cancellations of elective/planned surgical operations on DOS across urban secondary and tertiary level hospitals. We audited surgical records of a pre-decided period of six weeks for cancellations, documented relevant demographic information and reasons for cancellations. RESULTS: We analysed records from the participating hospitals, with an overall cancellation rate of 9.7% (508/5231) on the DOS for elective surgical operations. Of these, 74% were avoidable cancellations. A majority (30%) of these 508 cancellations were attributed to insufficient resources, 28% due to patient's refusal or failure to show-up, and 22% due to change in patient's medical status. CONCLUSION: We saw a preponderance of avoidable reasons for elective surgery cancellations. A multidisciplinary approach with adequate preoperative patient counselling, timely communication between the patients and caregivers, adequate preoperative anaesthetic assessment, and planning by the surgical team may help reduce the cancellation rate.

An Analysis of 30-Day in-Hospital Trauma Mortality in Four Urban University Hospitals Using the Australia India Trauma Registry.

BACKGROUND: India has one-sixth (16%) of the world's population but more than one-fifth (21%) of the world's injury mortality. A trauma registry established by the Australia India Trauma Systems Collaboration (AITSC) Project was utilized to study 30-day in-hospital trauma mortality at high-volume Indian hospitals. METHODS: The AITSC Project collected data prospectively between April 2016 and March 2018 at four Indian university hospitals in New Delhi, Mumbai, and Ahmedabad. Patients admitted with an injury mechanism of road or rail-related injury, fall, assault, or burns were included. The associations between demographic, physiological on-admission vitals, and process-of-care parameters with early (0-24 h), delayed (1-7 days), and late (8-30 days) in-hospital trauma mortality were analyzed. RESULTS: Of 9354 patients in the AITSC registry, 8606 were subjected to analysis. The 30-day mortality was 12.4% among all trauma victims. Early (24-h) mortality was 1.9%, delayed (1-7 days) mortality was 7.3%, and late (8-30 days) mortality was 3.2%. Abnormal physiological parameters such as a low SBP, SpO2, and GCS and high HR and RR were observed among non-survivors. Early initiation of trauma assessment and monitoring on arrival was an important process of care indicator for predicting 30-day survival. CONCLUSIONS: One in ten admitted trauma patients (12.4%) died in urban trauma centers in India. More than half of the trauma deaths were delayed, beyond 24 h but within one week following injury. On-admission physiological vital signs remain a valid predictor of early 24-h trauma mortality.

Estimation of the National Surgical Needs in India by Enumerating the Surgical Procedures in an Urban Community Under Universal Health Coverage.

BACKGROUND: 11% of the global burden of disease requires surgical care or anaesthesia management or both. Some studies have estimated this burden to be as high as 30%. The Lancet Commission for Global Surgery (LCoGS) estimated that 5000 surgeries are required to meet the surgical burden of disease for 100,000 people in LMICs. Studies from LMICs, estimating surgical burden based on enumeration of surgeries, are sparse. METHOD: We performed this study in an urban population availing employees' heath scheme in Mumbai, India. Surgical procedures performed in 2017 and 2018, under this free and equitable health scheme, were enumerated. We estimated the surgical needs for national population, based on age and sex distribution of surgeries and age standardization from our cohort. RESULT: A total of 4642 surgeries were performed per year for a population of 88,273. Cataract (22.8%), Caesareans (3.8%), surgeries for fractures (3.27%) and hernia (2.86%) were the commonest surgeries. 44.2% of surgeries belonged to the essential surgeries. We estimated 3646 surgeries would be required per 100,000 Indian population per year. One-third of these surgeries would be needed for the age group 30-49 years, in the Indian population. CONCLUSION: A total of 3646 surgeries were estimated annually to meet the surgical needs of Indian population as compared to the global estimate of 5000 surgeries per 100,000 people. Caesarean section, cataract, surgeries for fractures and hernia are the major contributors to the surgical needs. More enumeration-based studies are needed for better estimates from rural as well as other urban areas.

Ultrasound-Guided Microwave Ablation for the Management of Inguinal Neuralgia: A Preliminary Study with 1-Year Follow-up.

PURPOSE: To evaluate the feasibility and efficacy of ultrasound-guided microwave ablation for the treatment of inguinal neuralgia. MATERIALS AND METHODS: A retrospective review of 12 consecutive ultrasound-guided microwave ablation procedures was performed of 10 consecutive patients (8 men, 2 women; mean age, 41 years [range, 15-64 years]), between August 2012 and August 2016. Inclusion criteria for inguinal neuralgia included clinical diagnosis of chronic inguinal pain (average, 17.3 months [range, 6-46 months]) refractory to conservative treatment and a positive nerve block. Pain response-reduction of pain level and duration and percent pain reduction using a 10-point visual analog scale (VAS) at baseline and up to 12 months after the procedure-was measured. Nine patients had pain after the inguinal hernia repair, and 1 patient had pain from the femoral artery bypass procedure. The microwave ablation procedure targeted the ilioinguinal nerve in 7 cases, the genitofemoral nerve in 4 cases, and the iliohypogastric nerve in 1 case. RESULTS: Average baseline VAS pain score was 6.1 (standard deviation, 2.5). Improved pain levels immediately after the procedure and at 1, 6, and 12 months were statistically significant (P = .0037, .0037, .0038, .0058, respectively). Also, 91.7% (11/12) of the procedures resulted in immediate pain relief and at 1 month and 6 months. At 12 months, 83.3% (10/12) of patients had an average of 69% ± 31% pain reduction. Percent maximal pain reduction was 93% ± 14% (60%-100%), and the average duration of clinically significant pain reduction was 10.5 months (range, 0-12 months.). No complications or adverse outcomes occurred. CONCLUSIONS: Ultrasound-guided microwave ablation is an effective technique for the treatment of inguinal neuralgia after herniorrhaphy.

Study of doxofylline and its degradation products in bulk drug by a newly developed stability-indicating HPLC method.

The purpose of this work was to study the stability behavior of doxofylline under different stress conditions and to develop a sensitive stability-indicating HPLC assay method. The stress conditions applied included heat, moisture, acid-base hydrolysis, oxidation, and UV light. The drug was particularly labile under oxidative and thermal stress conditions, with 58.40 and 53.90% degradation, respectively. Good resolution of drug from degradation products formed under stress conditions was achieved on a C18 column using 10 mM KH2PO4 buffer solution (pH 6) methanol (40 + 60, v/v) as the mobile phase (pH 7.2). The flow rate was 1 mLlmin, and the detection wavelength was 273 nm. The method was validated for linearity, range, precision, accuracy, LOD, and LOQ. The RSD was found to be <2%. Since the method effectively separates the drug from its degradation products, it can be used as a stability-indicating method.

A developed and validated stability-indicating reverse-phase high performance liquid chromatographic method for determination of cefdinir in the presence of its degradation products as per International Conference on Harmonization guidelines.

The present article deals with the development and validation of a stability-indicating, reverse-phase high performance liquid chromatographic (RP-HPLC) method, for the determination of cefdinir on a Waters RP Spherisorb C-18 column (250 mm × 4.6 mm, 5 µm). A mobile phase consisting of water (pH adjusted to 3.0 with orthophosphoric acid) : acetonitrile : methanol 13:5:2 (v/v/v) was used. The flow rate was 1 mL min(-1). The separation was performed at room temperature. Detection was carried out at 286 nm, using a PDA detector. The developed method was statistically validated for the linearity, accuracy, specificity, Limit of Detection (LOD), and Limit of Quantitation (LOQ). The specificity of the method was ascertained by forced degradation studies, by acid and alkali degradation, oxidation, photolysis, and heat degradation. The degraded products were well-separated from the analyte, with significant differences in their retention time values. The Beer Law was obeyed over a concentration range of 0.05 - 15.00 µg mL(-1) and the correlation coefficient was 0.999.

Stress degradation studies and development of a validated stability-indicating-assay-method for determination of diacerein in presence of degradation products.

BACKGROUND: To understand the degradation behavior of diacerein and to develop a simple, rapid, sensitive, and validated RP-HPLC method for the determination of diacerein, in the presence of its degradation products. MATERIALS AND METHODS: An accurate, sensitive, precise, rapid, and isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method, equipped with a photo-diode array (PDA) detector for analysis of diacerein in the bulk drug has been developed and validated. The best separation was achieved on a 250 mm × 4.6 mm i.d., 5-µm particle, RP C18 column with 50 : 50 (v/v) of water (pH adjusted to 2.9 with orthophosphoric acid) : acetonitrile as the mobile phase, at a flow rate of 1.0 ml/minute. The detection wavelength was set at 257 nm. RESULTS: The response was a linear function of concentration over the range of 0.50 - 20 µg/ml (r = 0.999) and the limits of detection and quantitation were 0.1 µg/ml and 0.50 µg/ml, respectively. The method was validated in accordance with the International Conference on Harmonization (ICH) guidelines. The drug was subjected to oxidative, hydrolytic, photolytic, and thermal stress. The drug decomposed under alkaline hydrolytic stress conditions and also on thermal degradation and photolysis. It was stable on acid hydrolysis and oxidation. The degradation products produced as a result of this stress did not interfere with the detection of diacerein, and the assay could thus be regarded as stability-indicating. CONCLUSION: The method was suitable for application in the analysis of formulations of diacerein in quality-control laboratories, because it was simple and rapid, with good accuracy and precision.