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分光光度法测定新戊酸氟米松和氯碘羟喹二元混合物及药物制剂中的含量

Novel spectrophotometric determination of flumethasone pivalate and clioquinol in their binary mixture and pharmaceutical formulation.

作者信息

Abdel-Aleem Eglal A, Hegazy Maha A, Sayed Nour W, Abdelkawy M, Abdelfatah Rehab M

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., 11562 Cairo, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2015 Feb 5;136 Pt B:707-13. doi: 10.1016/j.saa.2014.09.085. Epub 2014 Sep 30.

DOI:10.1016/j.saa.2014.09.085
PMID:25448970
Abstract

This work is concerned with development and validation of three simple, specific, accurate and precise spectrophotometric methods for determination of flumethasone pivalate (FP) and clioquinol (CL) in their binary mixture and ear drops. Method A is a ratio subtraction spectrophotometric one (RSM). Method B is a ratio difference spectrophotometric one (RDSM), while method C is a mean center spectrophotometric one (MCR). The calibration curves are linear over the concentration range of 3-45 μg/mL for FP, and 2-25 μg/mL for CL. The specificity of the developed methods was assessed by analyzing different laboratory prepared mixtures of the FP and CL. The three methods were validated as per ICH guidelines; accuracy, precision and repeatability are found to be within the acceptable limits.

摘要

本研究致力于开发并验证三种简单、特异、准确且精密的分光光度法,用于测定二丙酸氟替卡松(FP)和氯碘羟喹(CL)二元混合物及滴耳液中的FP和CL。方法A是比值减法分光光度法(RSM)。方法B是比值差分光光度法(RDSM),而方法C是平均中心分光光度法(MCR)。校准曲线在FP浓度范围为3 - 45μg/mL、CL浓度范围为2 - 25μg/mL时呈线性。通过分析不同实验室配制的FP和CL混合物来评估所开发方法的特异性。这三种方法按照ICH指南进行了验证;准确度、精密度和重复性均在可接受范围内。

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