摘要
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。
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.
出处
《中国药品标准》
CAS
2008年第3期221-223,共3页
Drug Standards of China
关键词
高效液相色谱法
氨酸伪麻那敏胶囊
马来酸氯苯那敏
盐酸伪麻黄碱
HPLC
Compound Pseudoephedrine Hydrechloride Capsules
Chlorphenamine Maleate, Pseudoephedrine Hydrechloride
