分光光度法和薄层色谱-密度法同时测定二甲双胍和吡格列酮中二甲双胍杂质的含量

A. Khorshid, Nessreen S. Abdelhamid, Eglal A. Abdelaleem, Mahmoud Mohsen Amin
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引用次数: 5

摘要

采用分光光度法和薄层色谱法同时测定原料药和制剂中二甲双胍杂质三聚氰胺中盐酸二甲双胍和盐酸吡格列酮的含量。方法A采用零阶分光光度法在268nm处测定吡格列酮,采用等吸收点分光光度法在255 nm处测定二甲双胍,采用双除数法在254 nm处测定二甲双胍。方法B采用薄层色谱密度测定技术,以甲苯/甲醇/乙酸(5:5:5 .5)为显影体系,扫描波长为240nm,对三种药物进行分离同时测定。根据ICH指南对该方法进行了验证,并显示出良好的准确性和精密度。
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 Metformin and Pioglitazone in Presence of Metformin Impurity by Different Spectrophotometric and TLC – Densitometric Methods
New simple accurate methods were developed and validated for simultaneous determination of Metformin hydrochloride and Pioglitazone hydrochloride in presence of Metformin impurity Melamine , both in bulk powder and in pharmaceutical preparation using spectrophotometric methods and thin layer chromatography . Method A used zero order spectrophotometric technique for determination of Pioglitazone at 268nm and isoabsorbtive point spectrophotometric technique to determine Metformine at 255 nm in presence of the other drugs and used double divisor technique to determine Metformine in presence of the other drugs at 254 nm. Method B uses TLC densitometric technique for separation and simultaneous determination of the three drugs using toluene / methanol / acetic acid (5:5:0.5) as a developing system and 240nm as a scanning wavelength. This method were validated and shown to demonstrate good accuracy and precision according to ICH guidelines.
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