毛细管电泳法同时测定制剂中左旋咪唑和羟氯胺的含量

A. Ahmed, M. Nassar, A. El-Olemy, Mohamed S. Emara
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引用次数: 1

摘要

建立了一种灵敏、精确、准确的毛细管电泳同时测定左旋咪唑和羟氯胺的方法。毛细管电泳是一种简便的分离分析方法,可在较短的分析时间内同时分析药物。在本研究中,分离是在熔融石英毛细管(30 cm - 50µm内径)上实现的;背景电解质溶液由磷酸盐缓冲液(40 mM, pH 7.9)和227 nm紫外检测组成。结果表明,该方法具有良好的线性(r 2 > 0.9998)、精密度(RSD <0.193%)、准确度(左旋咪唑回收率为99.95%,羟氯胺回收率为100.12%)、特异性和稳健性。左旋咪唑的LOD和LOQ分别为0.099µg mL -1和0.299µg mL -1,羟氯胺的LOD和LOQ分别为0.075µg mL -1和0.228µg mL -1。该方法分离效果好,精度高。该方法根据ICH指南进行了验证,并用于所引用药物制剂的测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
SIMULTANEOUS DETERMINATION OF LEVAMISOLE AND OXYCLOZANIDE IN THE PHARMACEUTICAL PREPARATION BY CAPILLARY ELECTROPHORESIS
A sensitive, precise and accurate capillary electrophoresis method was developed for simultaneous determination of levamisole and oxyclozanide in pure sample and pharmaceutical preparation. Capillary electrophoresis was presented as a simple separation analytical method for the simultaneous analysis of the deliberated drugs within a shorter analytical run time. In this study, separation was achieved on fused silica capillary (30 cm - 50 µm internal diameter); background electrolyte solution consisted of phosphate buffer (40 mM, pH 7.9) and UV detection at 227 nm. The method showed to be linear (r 2 > 0.9998), precise (RSD <0.193%), accurate (recovery of 99.95% for levamisole and 100.12% for oxyclozanide), specific and robust. LOD and LOQ values were 0.099 µg mL -1 and 0.299 µg mL -1 respectively for levamisole and 0.075 µg mL -1 and 0.228 µg mL -1 respectively for oxyclozanide. The proposed method obtained well separation and had a perfect accuracy. The method was validated according to ICH guidelines and carried out for determination of the cited drugs in their pharmaceutical preparation.
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