氨酚伪麻那敏胶囊中马来酸氯苯那敏和盐酸伪麻黄碱含量测定方法的改进

目的：建立氨酚伪麻那敏胶囊中马来酸氯苯那敏和盐酸伪麻黄碱的含量测定方法。方法：采用HPLC法测定，C18柱（4.6mm×200mm，5μm），以乙腈-0.5％十二烷基硫酸钠-磷酸（57：43：0.02）为流动相，流速为1mL·min^-1，检测波长为221nm，进样量：20μL。结果：马来酸氯苯那敏和盐酸伪麻黄碱线性范围分别为0.2044～1．0220和2．134～10．670μg；平均回收率（n=9）分别为100.4％（RSD为1，1％）和99.7％（RSD为0.7％）。结论：方法简便、准确，可为评价氨酚伪麻那敏胶囊中马来酸氯苯那敏盐酸伪麻黄碱的含量提供依据。

Determination of Chlorphenamine Maleate and Pseudoephedrine Hydrochloride in Compound Pseudoephedrine Hydrochloride Capsules by HPLC

Objective：To establish a method for the determination of Chlorphenamine Maleate and Pseudoephedrine Hydrochloride in Compound Pseudoephedrine Hydrochloride Capsules. Methods：The HPLC column was C ts （4. 6 mm × 200 mm,5 μm） ;the mobile phase was acetonitrile-0. 5% sodium laurylsulfate solution-phosphoric acid （57： 43： 0. 02 ） ; the flow rate was 1 mL · min^- 1, the UV detection wavelength was 221 nm, room temperature for column. Injection volume was 20 μL Results：The calibration curves of Chlorphenamine Maleate and Pseudoephedrine Hydrochloride were linear in the range of 0. 204 4 - 1. 022 0 and 2. 134 - 10. 670 μg respectively;The average recoveries（ n = 9） were 100. 4% （ RSD 1.1% ） and 99. 7 % （ RSD 0. 7% ） respectively. Conclusion： The method is rapid,accurate and reliable.