Development and validation of stability indicating liquid chromatographic (RP-HPLC) method for estimation of ubidecarenone in bulk drug and formulations using quality by design (QBD) approach

ABSTRACT A novel, accurate, precise and economical stability indicating Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method, was developed and validated for the quantitative determination of ubidecarenone (UDC) in bulk drug, UDC marketed formulation and UDC loaded cubosomes (CBMs) nanocarriers through Response surface methodology (RSM) design with three factors and three levels was performed to optimize the chromatographic variables followed by forced degradation studies of UDC were performed to detect degradation peak. RP-HPLC separation was achieved using mobile phase consisting of Acetonitrile:Tetrahydrofuran:Deionised water in the ratio 55:42:3 and a flow rate of 1.0 mL/min was optimized with a standard retention time (Rt) of 2.15 min, through experiment. The method was found linear in the concentration range of 5-100 µg/mL with a regression coefficient of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 3.04 µg/mL and 9.11 µg/mL, respectively.

Long-term neuropsychological effects of opioid use in children: a descriptive literature review.

BACKGROUND: Use of opioids in the management of pain and its consequences in children presents a substantial challenge. A significant concern in pediatric pain management is the long-term neuropsychological consequences of opioids. OBJECTIVES: The authors aim to provide a descriptive review of the current literature surrounding the neuropsychological impact of opioid use in children, along with possible extrapolations from their use in adults and animal models. STUDY DESIGN: Systematic review of published literature. SETTING: Various universities in the United States. METHODS: The electronic review for papers published between January 1992 and December 2012 was conducted using Medline/Pubmed, PsychInfo, CINAHL, the Cochrane Library database, and Google Scholar. RESULTS: Findings assessing pediatric pain patients treated with opioids demonstrated no significant differences in intelligence, behavior, vocabulary, or motor skills. One study reported a decrease in a visuo-constructional ability, which measured higher order executive function. Studies from prenatal illicit opioid exposure found poorer performance on measures of language, verbal ability, mathematics, reading, impulse control, and school readiness skills. The literature from adult prescribed opioid users has mixed results. Some showed impairment in the neuropsychological domains of memory, decision-making, attention, concentration, information processing, psychomotor speed, visual special skills, and hand-eye coordination, while others found no differences or revealed improved perceptual-cognitive status, possibly due to the removal of pain as a stressor. LIMITATIONS: Very few studies looked into the long term neuropsychological and cognitive effects of the opioids in pediatric population. In an attempt to extrapolate from other groups, this review also included literature from adult patients, prenatal opioid exposure, and animal studies. CONCLUSION: Opioid medications have the potential to produce long-lasting neuropsychological side effects. However, given the negative consequences of untreated pain, the potential benefit may offset their risk. More studies are needed to clarify this complex interaction.