探索新型等容高效液相色谱法定量测定肉桂利嗪和吡拉西坦胶囊制剂中的含量

S. El-Adl, M. El-Sadek, Hasan Mh
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引用次数: 5

摘要

建立了一种新型的等密度高效液相色谱法,可在10分钟内快速同时分离和测定肉桂利嗪和吡拉西坦的纯度或制剂。采用Hypersil gold C18 (10μm, 100x4.6mm)色谱柱进行分离。研究了pH、流动相组成、流速等因素对分离效果的影响。肉桂嗪在(10 ~ 80)μg/ml范围内,吡拉西坦在(160 ~ 960)μg/ml范围内进行校准。该方法适用于原料药和制剂的同时测定,首次采用等密度高效液相色谱法测定复方肉桂利嗪和吡拉西坦,并根据ICH参数对方法进行了验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Exploring Novel Isocractic HPLC Method for Quantitative Determination of Cinnarizine and Piracetam in Their Capsule Preparations
A novel isocratic HPLC method had been developed for rapid simultaneous separation and determination of cinnarizine and Piracetam in pure form or in pharmaceutical formulations within less than 10 minutes. Separation was carried out on a Hypersil gold C18 (10μm, 100x4.6mm) column. Effect of pH and composition of mobile phase in addition to flow rate was studied. Calibration was obeyed in the range of (10-80) μg/ml for cinnarizine or (160- 960) μg/ ml for Piracetam. The method was applied for the simultaneous determination of these drugs in both bulk and pharmaceutical forms and this is the first published method that uses isocratic HPLC method for cinnarizine and piracetam determination in combined formulation and the method were validated according to ICH parameters.
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