摘要
目的建立HPLC法测定复方甲氧那明胶囊中盐酸甲氧那明、氨茶碱、那可汀和马来酸氯苯那敏的溶出度。方法按照中国药典2010年版二部溶出度测定方法第一法,以0.1 mol·L^(-1)盐酸500 m L为溶出介质,转速为100 r·min^(-1),测定盐酸甲氧那明、氨茶碱、那可汀和马来酸氯苯那敏的浓度。采用Agilent C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.04 mol·L^(-1)磷酸二氢钾溶液-三乙胺(335∶500∶0.2),检测波长为230 nm。结果该方法氨茶碱、盐酸甲氧那明、那可汀、马来酸氯苯那敏线性范围分别为15.576~62.304μg·m L^(-1)、9.832~39.328μg·m L^(-1)、5.772~23.088μg·m L^(-1)、1.6264~6.5056μg·m L^(-1);回收率分别为99.4%(RSD=0.59%)、99.5%(RSD=0.69%)、99.3%(RSD=0.69%)、100.4%(RSD=0.73%)。结论本法简便、准确、操作简单,能有效控制产品质量。
Objective To determine the dissolution of methoxyphenamine hydrochloride, aminophylline, narcotin, chlorprophenpyridamine maleate in compound methoxyphenamine capsules by HPLC method. Methods Referring to Pharmacopoeia of the people’s republic of China（2010） Volume Ⅱ, Appendix ⅩCⅠ, 500 m L 0.1 mol·L-1 hydrochloride was used as dissolution medium and apparatus of 100 r·min-1. HPLC method was used to determine the dissolution of compound in methoxyphenamine capsules. An agilent C18（250 mm×4.6 mm, 5 μm） was used with the mobile phase of methol-0.04 mol·L-1 potassium phosphate monobasic solution- triethylamine（335∶500∶0.2） at 230 nm. Results The linearity of aminophylline, methoxyphenamine hydrochloride, narcotin, and chlorprophenpyridamine maleate was at 15.576- 62.304 μg·m L-1, 9.832- 39.328 μg·m L-1, 5.772- 23.088 μg·m L-1, 1.6264- 6.5056 μg·m L-1, respectively. The recovery rate of aminophylline, methoxyphenamine hydrochloride, narcotin, chlorprophenpyridamine maleate was 99.4%（RSD = 0.59%）, 99.5%（RSD = 0.69%）, 99.3%（RSD = 0.69%）, 100.4%（RSD = 0.73%）, respectively. Conclusion This method is simple, accurate, and can be used to control the quality of the product.
出处
《中南药学》
CAS
2016年第6期655-658,共4页
Central South Pharmacy
