HPLC法测定复方苯海拉明麻黄碱糖浆中麻黄碱、苯海拉明含量.docVIP

HPLC法测定复方苯海拉明麻黄碱糖浆中麻黄碱、苯海拉明含量 　　[摘要] 目的:研究并建立同时测定复方苯海拉明麻黄碱糖浆中盐酸麻黄碱、盐酸苯海拉明含量的HPLC法。方法:采用Sino Chrom ODS-BP C18(200 mm×4.6 mm,5 μm)色谱柱,流动相为0.02 mol/L十二烷基硫酸钠溶液-乙腈-三乙胺(48∶52∶0.1),用磷酸调节pH至(3.50±0.05),流速为0.8 ml/min,检测波长为257 nm,柱温为35℃。结果:盐酸麻黄碱、盐酸苯海拉明的线性范围分别为0.585 6~5.856 0 μg(r=0.999 9)和0.508 4~5.084 0 μg(r=0.999 9),平均回收率分别为98.3%(RSD=1.01%)和98.5%(RSD=1.12%)。结论:该法快速、简便、准确,可用于复方苯海拉明麻黄碱糖浆的质量控制。 　　[关键词] 复方苯海拉明麻黄碱糖浆;盐酸麻黄碱;盐酸苯海拉明;高效液相色谱法 　　[中图分类号]R927.2 [文献标识码]A [文章编号]1673-7210(2009)07(c)-042-03 　　 　　Content determination of ephedrine hydrochloride and diphenhydramine hydrochloride in Compound Diphenhydramine Hydrochloride and Ephedrine Hydrochloride Syrup by HPLC 　　ZHANG Tao 　　(Anyang Institute for Food and Drug Control, Anyang 455000, China) 　　[Abstract] Objective: To establish a method for determining the contents of ephedrine hydrochloride and diphenhydramine hydrochloride in Compound Diphenhydramine Hydrochloride and Ephedrine Hydrochloride Syrup simultaneously. Methods: RP-HPLC was used with a Sino Chrom ODS-BP C18 column (200 mm×4.6 mm, 5 μm), the mobile phase was a mixture of 0.02 mol/L sodium laurylsulfate solution-scetonitrile-triethanolamine (48∶52∶0.1), the flow rate was 0.8 ml/min and the detection wavelength was 257 nm, the column temperature was 30℃. Results: The linear range was within 0.585 6-5.856 0 μg(r=0.999 9), the average recovery was 98.3%(RSD=1.01%) for ephedrine hydrochloride; and the linear range was within 0.508 4-5.084 0 μg(r=0.999 9), the average recovery was 98.5%(RSD=1.12%) for diphenhydramine hydrochloride. Conclusion: The method is fast, simple and accurate, it can be used for the quality control of Compound Diphenhydramine Hydrochloride and Ephedrine Hydrochloride Syrup. 　　[Key words] Compound Diphenhydramine Hydrochloride and Ephedrine Hydrochloride Syrup; Ephedrine hydrochloride; Diphenhydramine hydrochloride; HPLC 　　 　　复方苯海拉明麻黄碱糖浆又名止喘咳糖浆,有效成分由盐酸苯海拉明、枸橼酸喷托维林、盐酸麻黄碱、氯化铵等组成,具有祛痰、镇咳、平喘的作用,主要用于支气管哮喘并伴有咳嗽者,亦可用于感冒引起的咳嗽、多痰。其质量标准收载于《国家药品标准:化