期刊名称：Beni-Suef University Journal of Basic and Applied Sciences
印刷版ISSN：2314-8535
电子版ISSN：2314-8543
出版年度：2014
卷号：3
期号：1
页码：52-62
DOI：10.1016/j.bjbas.2014.02.007
语种：English
出版社：Elsevier
摘要：AbstractAccurate, selective and sensitive stability indicating high performance thin layer chromatographic (HPTLC) method was developed and validated for determination of Metopimazine (MPZ) in presence of its degradation products; including the oxidative degradation product (Deg I) and the alkaline hydrolysis degradation product (Deg II; formerly reported as acid metabolite). The proposed method was applied for analysis of MPZ in pure form, pharmaceutical formulation (tablets) and human plasma over the concentration range of 0.4–1.4 μg band−1with accuracy of mean percentage recovery 100.10 ± 0.941. The method depends on separation of MPZ from its degradation products on HPTLC silica gel 60 F254plates using chloroform–methanol–ammonia (12:2:0.1, by volume) as developing system followed by densitometric measurement of bands at 254 nm. The method was validated according to ICH guidelines. The degradation products were well resolved from the pure drug with significantly differentRfvalues (MPZ,Rf = 0.58, Deg I,Rf = 0.35 and Deg II,Rf = 0.03). The results obtained by the proposed method were statistically compared to the reported HPTLC method, and there was no significant difference between them regarding both accuracy and precision; indicating the ability of the proposed method to be used for routine analysis of drug product.
