Corrigendum to "Novel approach for infrared spectroscopic quantitation of azithromycin in commercial tablets employing paracetamol as matrix modifier" [Heliyon 9 (3) (March 2023) Article e14647].

[This corrects the article DOI: 10.1016/j.heliyon.2023.e14647.].

Novel approach for infrared spectroscopic quantitation of azithromycin in commercial tablets employing paracetamol as matrix modifier.

The ATR-FTIR quantitation of azithromycin in three products of commercial tablets was carried out on product specific quantitative regression models using powdered paracetamol as matrix modifier to overcome the variation of spectral response and influence of sample matrix. For each product, a PLS quantitative regression model was established using training infrared spectra obtained from reference mixtures (reference powders with known mass content (%, w/w) of azithromycin mixed homogenously with paracetamol to have mass percentage of azithromycin over total mass of azithromycin and paracetamol (PA) from 30% to 70%). The spectral data were collected in wavenumber range depending on commercial product within the wavenumber zone from 1300 cm-1 to 1750 cm-1 to build quantitative regression models. To quantify azithromycin in any commercial batch of the same product, the homogenized sample powder was mixed with paracetamol to have mixtures with PA value about 50% to record infrared spectrum. The actual amount of azithromycin would then be calculated from spectral response of unknown sample and the pre-established quantitative regression model. Each quantitative regression model was validated according to the current requirements of ICH guideline Q2R1 and those of AOAC International in term of specificity, accuracy, precision, long-term robustness and reliability. The validation results proved that the quantitative regression models were accurate, precise, reliable and robust, able to provide quantitative results of azithromycin in tablets equivalent to those provided by official HPLC method of USP44.

Green, Cost-Effective Simultaneous Assay of Chloramphenicol, Methylparaben, and Propylparaben in Eye-Drops by Capillary Zone Electrophoresis.

A green, cost-effective, and simple capillary zone electrophoresis (CZE) method was developed and validated for simultaneous determination of chloramphenicol, methylparaben, and propylparaben in eye-drops. With sodium tetraborate as background electrolyte (BGE), the apparent mobilities of chloramphenicol, methylparaben, and propylparaben increased and analysis time reduced when pH of BGE increased from 8.5 to 10.0 and concentration of BGE decreased from 40 mM to 15 mM, but complete separation of chloramphenicol from other matrix components was achieved only with sodium tetraborate concentration at 30 mM or higher and at pH = 9.3 or lower. The most suitable electrophoretic conditions for the intended application were a 30 mM sodium tetraborate solution, pH 9.3 as BGE, working voltage set at 25 kV, and UV detection at 280 nm at the cathodic extremity of the capillary. The final method was validated and proved to be reliable for assay of chloramphenicol, methylparaben, and propylparaben in eye-drops.

Population Pharmacokinetics and Dose Optimization of Ceftazidime and Imipenem in Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease.

BACKGROUND: Ceftazidime and imipenem have been increasingly used to treat Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) due to their extended-spectrum covering Pseudomonas aeruginosa. This study aims to describe the population pharmacokinetic (PK) and pharmacodynamic (PD) target attainment for ceftazidime and imipenem in patients with AECOPD. METHODS: We conducted a prospective PK study at Bach Mai Hospital (Viet Nam). A total of 50 (ceftazidime) and 44 (imipenem) patients with AECOPD were enrolled. Population PK analysis was performed using Monolix 2019R1 and Monte Carlo simulations were conducted to determine the optimal dose regimen with respect to the attainment of 60% and 40% fT>MIC for ceftazidime and imipenem, respectively. A dosing algorithm was developed to identify optimal treatment doses. RESULTS: Ceftazidime and imipenem PK was best described by a one-compartment population model with a volume of distribution and clearance of 23.7 L and 8.74 L/h for ceftazidime and 15.1 L and 7.88 L/h for imipenem, respectively. Cockcroft-Gault creatinine clearance represented a significant covariate affecting the clearance of both drugs. Increased doses with prolonged infusion were found to cover pathogens with reduced susceptibility. CONCLUSIONS: This study describes a novel and versatile three-level dosing algorithm based on patients' renal function and characteristic of the infective pathogen to explore ceftazidime and imipenem optimal regimen for AECOPD.

Development and Validation of a Simple, Green Infrared Spectroscopic Method for Quantitation of Sildenafil Citrate in Siloflam Tablets of Unknown Manufacturing Formula.

A simple, easy-to-implement, and green infrared spectroscopic method was developed and validated for the quantitative determination of sildenafil citrate in tablets of unknown manufacturing formula. Homogenized tablet powder with known mass content (%, m/m) of sildenafil citrate was mixed with paracetamol to form standard mixtures with different percentages of sildenafil citrate on the total quantity of sildenafil citrate and paracetamol (designated as R). Unknown tablet samples were finely ground and mixed with paracetamol to form test mixtures having R values about 50%. Infrared spectra of standard mixtures, measured in attenuated total reflectance mode, in the wavenumber zone from 1800 cm-1 to 1300 cm-1 were selected and processed by partial least square regression to form the calibration model for quantitation of sildenafil citrate in unknown samples. Spectral responses of test mixtures and the calibration model were used to determine the exact mass content (%, m/m) of sildenafil citrate in the powder of unknown tablet samples. The method was fully validated in terms of linearity, precision, and accuracy according to the requirements of current guidelines and was proved as reliable and suitable for the intended application.

Low-cost and versatile analytical tool with purpose-made capillary electrophoresis coupled to contactless conductivity detection: Application to antibiotics quality control in Vietnam.

In this study, the development of our purpose-made capacitively coupled contactless conductivity detection (C4 D) for CE is reported. These systems have been employed as a simple, versatile, and cost-effective analytical tool. CE-C4 D devices, whose principle is based on the control of the ion movements under an electrical field, can be constructed even with a modest financial budget and limited infrastructure. A featured application was developed for quality control of antimicrobial drugs using CE-C4 D, with most recent work on determination of aminoglycoside and glycopeptide antibiotics being communicated. For aminoglycosides, the development of CE-C4 D methods was adapted to two categories. The first one includes drugs (liquid or powder form) for intravenous injection, containing either amikacin, streptomycin, kanamycin A, or kanamycin B. The second one covers drugs for eye drops (liquid or ointment form), containing either neomycin, tobramycin, or polymyxin. The CE-C4 D method development was also made for determination of some popular glycopeptide antibiotics in Vietnam, including vancomycin and teicoplanin. The best detection limit achieved using the developed CE-C4 D methods was 0.5 mg/L. Good agreement between results from CE-C4 D and the confirmation method (HPLC- Photometric Diode Array ) was achieved, with their result deviations less than 8% and 13% for aminoglycoside and glycopeptide antibiotics, respectively.

Simultaneous Assay of Dexchlorpheniramine Maleate, Betamethasone, and Sodium Benzoate in Syrup by a Reliable and Robust HPLC Method.

The simultaneous determination of betamethasone, dexchlorpheniramine maleate, and sodium benzoate in pharmaceutical syrup was done by using a simple validated HPLC method. The chromatographic separation of the three analytes was done in a C18 column maintained at 25°C, using a mixture of acetonitrile and 0.02 M phosphate buffer solution pH 2.70 (35 : 65, v : v) as mobile phase. The isocratic elution was chosen with total flow rate of mobile phase maintained at 1.0 mL per minute. The analytes were detected by a UV-Vis detector set at 254 nm. Injection volume was set at 50 µl. The method was fully validated in terms of specificity, linearity, precision, accuracy, and robustness according to requirements of current guidelines and was proven to be suitable for the intended application.

Development and Validation of an HPLC Method for Simultaneous Assay of MCI and MI in Shampoos Containing Plant Extracts.

A simple, easy-to-implement HPLC method was developed and validated for simultaneous determination of two isothiazolinone preservatives, methylchloroisothiazolinone (MCI) and methylisothiazolinone (MI), in hair care shampoo containing plant extracts. In this method, shampoo samples were first dissolved in isopropyl myristate and then MCI and MI were extracted from isopropyl myristate layer by a mixture of methanol and 0.02 M phosphate buffer solution pH 3.0 (30: 70, v/v) and analyzed on an analytical biphenyl column maintained at 25°C with a mixture of methanol and water (10: 90, v/v) in isocratic elution mode as mobile phase. Total flow rate of mobile phase was maintained at 1.0 mL per minute. The UV detection was performed at 274 nm. Injection volume was 50 µl. The method was fully validated in terms of specificity, linearity, precision, accuracy, and robustness according to requirements of AOAC International and was proved as reliable and suitable for the intended application.

Cost-effective capillary electrophoresis with contactless conductivity detection for quality control of beta-lactam antibiotics.

A simple and inexpensive approach for determination of various antimicrobial drugs using a purpose-made compact capillary electrophoresis (CE) instrument with capacitively coupled contactless conductivity detection (C4D) is reported. The objective of the work is to propose an affordable and easily-implemented tool for quality control and detection of counterfeiting of antibiotic formulations in resource constrained developing countries. The design of the purpose-made CE-C4D system was improved according to the feedback from over 10 years of use of our previous instrument. CE-C4D methods were for the first time developed to analyze ß-lactam-based antibiotics commonly used in Vietnam, including single- ß-lactam antibiotics (i.e. Cephalexin, Cefotaxime Sodium, Cefixime and Sulbactam) as well as ß-lactams co-formulated with Sulbactam (i.e. Amoxicillin, Ampicillin, Cefoperazone and Sulbactam). Single ß-lactam antibiotics were analyzed using a background electrolyte (BGE) composed of Tris/Ace (10 mM, pH 7.8) whereas ß-lactam - Sulbactam combinations were simultaneously separated using a BGE containing Tris/Ace (10 mM, pH 7.5). The best achieved detection limits were 2.0 mg/L and 1.0 mg/L for these two groups, respectively. Good agreement between results obtained from CE-C4D and standard confirmation methods (LCMS) was achieved, with a coefficient of determination, r2, of 0.9991. The applicability of the developed CE-C4D method was demonstrated for quality control of 24 ß-lactam-based antimicrobial drugs available in Vietnam.

Development and Validation of an HPLC Method for Simultaneous Assay of Potassium Guaiacolsulfonate and Sodium Benzoate in Pediatric Oral Powder.

A novel HPLC method was developed and validated for simultaneous determination of potassium guaiacolsulfonate and sodium benzoate in pediatric oral powder. In this method, an analytical C8 column maintained at 25°C was used for chromatographic separation with a mixture of methanol and 0.02 M solution of tetrabutylammonium sulfate as the mobile phase. The composition of mobile phase was varied using a gradient program including an initial hold time of 7 minutes with methanol content maintained at 20% (v/v), followed by a linear gradient in 5.5 minutes in which methanol content was increased from 20% (v/v) to 50% (v/v) and a final hold time of 2.5 minutes with methanol content maintained at 20% (v/v). The total flow rate of mobile phase was maintained at 1.0 mL per minute. The UV detection was performed at 280 nm. Injection volume was set at 20 µl. The method was fully validated in terms of specificity, linearity, precision, accuracy, and robustness according to requirements of current guidelines and was proved as reliable and suitable for the intended application.

Spatial and seasonal variation of diarrheic shellfish poisoning (DSP) toxins in bivalve mollusks from some coastal regions of Vietnam and assessment of potential health risks.

The occurrence of okadaic acid (OA) group toxins in bivalve mollusk collected from Vietnamese coastal areas was investigated from April 2016 to April 2017. OA group toxins were detected in mollusk by UPLC-MS/MS with the highest level of 11.3 ng/g and detection frequency of 11.8%. Toxins were detected more frequently in dry season (14.4% of analyzed samples) than in wet season (7.9%). Toxins were also detected more frequently at sampling locations in the northern parts (≥10.4%) than in the southern part (≤8.3%) of Vietnamese coastline. Results of this study were similar to those obtained in long-term studies in regions geographically close to Vietnam, confirming decisive influence of geographic location on the accumulation of toxins in mollusks. Within the scope of the study, toxin levels in all contaminated samples were below the regulation limit (160 ng/g), but the presence of OA group toxins in bivalve mollusk suggests the need of a more stringent control of toxins in bivalve mollusk in Vietnam.