复方酚咖伪麻胶囊含量均匀度测定

Determination of content uniformity of chlorphenamine maleate and cloperastine hydrochloride in Compound Paracetamol Caffeine and Pseudoephedrine Hydrochloride Capsules

目的:探讨高效液相色谱法(HPLC)测定复方酚咖伪麻胶囊中马来酸氯苯那敏和盐酸氯哌丁含量均匀度的方法。方法:采用HPLC,Waters X-Terra C18(4.6 mm×250 mm,5μm);1%醋酸溶液(用二乙胺调pH值至3.7)-甲醇(50∶50)为流动相;检测波长为226 nm。结果:马来酸氯苯那敏和盐酸氯哌丁进样量分别在0.13～2.56μg和0.60～12.01μg与峰面积的线性关系良好(r=0.99994和0.99999);平均回收率为99.90%,99.91%,101.68%和101.00%,100.12%,100.34%;精密度,重复性良好。结论:所建立的方法准确、简便、快速,适用于复方酚咖伪麻胶囊中马来酸氯苯那敏和盐酸氯哌丁含量均匀度的测定。

Objective ：To build up a HPLC method for the determination of content uniformity of chlorphenamine maleate and cloperastine hydrochloride in Compound Paracetamol Caffeine and Pseudoephedrine Hydroehloride Capsules.Methods：Using Waters X-Terra C18 （4.6mm×250mm,5 μm）, 1% acetic acid solution （ajusfing pH to 3.7 by diethyl amine）-methanol （50：50）was as the mobile phase,the detection wave-length was 226 nm.Results：The calibration curves showed good linearity of chlorphenamine maleate and cloperasfine hydroehloride over the range of 0.13-2.56 μg and 0.60-12.01μg,r=0.99994 and 0.99999;the average recovery rates were 99.90%, 99.91%, 101.68% and 101.00%, 100.12%, 100.34%.Precision and repeatability were good.Conclusion：The proposed method is accurate, simple,rapid and suitable for the determination of content uniformity of chlorphenamine maleate and cloperasfine in this preparation.