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首页> 外文期刊>European Journal of Medicinal Chemistry: Chimie Therapeutique >Development and validation of stability indicating HPLC and HPTLC methods for determination of sulpiride and mebeverine hydrochloride in combination.
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Development and validation of stability indicating HPLC and HPTLC methods for determination of sulpiride and mebeverine hydrochloride in combination.

机译：稳定性和稳定性的开发和验证表明，HPLC和HPTLC方法可同时测定舒必利和盐酸美贝维林。

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摘要

Validated sensitive and highly selective stability indicating methods are adopted for simultaneous quantitative determination of sulpiride and mebeverine hydrochloride in presence of their reported impurities and hydrolytic degradates whether in pure forms or in pharmaceutical formulation. The first method is High Performance Liquid Chromatography, where the mixture of sulpiride and mebeverine hydrochloride together with the reported interferents plus metopimazine as internal standard are separated on a reversed phase cyano column (5 microm ps, 250 mm x 4.6 id) using acetonitrile: water (70:30 v/v) adjusted to pH = 7 as a mobile phase. The drugs were detected at 221 nm over a concentration range of 5-40 microg ml(-1) and 5-60 microg ml(-1) with mean percentage recoveries 99.75% (S.D. 0.910) and 99.99% (S.D. 0.450) for sulpiride and mebeverine hydrochloride respectively. The second method is High Performance Thin Layer Chromatography, where sulpiride and mebeverine hydrochloride are separated on silica gel HPTLC F(254) plates using absolute ethanol:methylene chloride:triethyl amine (7:3:0.2 by volume) as mobile phase and scanning of the separated bands at 221 nm over a concentration range of 0.4-1.4 and 0.2-1.6 microg band(-1) with mean percentage recoveries 101.01% (S.D. 1.991) and 100.40% (S.D. 1.868) for sulpiride and mebeverine hydrochloride respectively.
机译：在已报告的杂质存在下，采用经过验证的灵敏且高度选择性的稳定性指示方法来同时定量测定舒必利和盐酸美贝维林，无论是纯净形式还是药物制剂，均会发生水解降解。第一种方法是高效液相色谱法，其中使用反相乙腈：水在反相氰基色谱柱（5微米ps，250毫米x 4.6内径）上分离磺必利和盐酸美贝维林的混合物以及所报告的干扰素和美托咪嗪作为内标。 （70:30 v / v）调节至pH = 7作为流动相。在221 nm处检测到浓度范围为5-40 microg ml（-1）和5-60 microg ml（-1）的药物，舒必利的平均回收率分别为99.75％（SD 0.910）和99.99％（SD 0.450）。和盐酸美贝维林。第二种方法是高效薄层色谱法，其中使用无水乙醇：二氯甲烷：三乙胺（体积比为7：3：0.2）作为流动相，在硅胶HPTLC F（254）板上分离硫必利和盐酸美贝维林。浓度为0.4-1.4和0.2-1.6 microg band（-1）时在221 nm处分离的谱带，舒必利和盐酸美比维林的平均回收率分别为101.01％（SD 1.991）和100.40％（SD 1.868）。

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