摘要
目的建立感特灵胶囊中马来酸氯苯那敏含量均匀度的测定方法。方法选择五批市售感特灵胶囊,采用Shim-Pack VP-ODS柱,以甲醇-0.05 mol.L-1磷酸二氢钠溶液-三乙胺(19∶81∶0.025)为流动相,检测波长为215 nm。结果马来酸氯苯那敏在0.116 4μg^0.349 2μg范围内呈良好线性关系(r=0.999 7,n=5),平均回收率为97.90%,RSD=2.83%;五批市售胶囊剂含量均匀度均不符合规定。结论此法简便、结果可靠,为感特灵胶囊的生产工艺改进提供参考。
Objective To develop a method for determining the content and uniformity of chlorphenamine maleate in Ganteling capsules by HPLC. Methods Using Shim-Pack VP-ODS C18 column with methanol-0.05mol · L^-1 sodium dihydrogen phosphate-triethylamine（19 ： 81 ： 0. 025）as mobile phase ,detection wavelength at 215nm. Five batches of capsules were selected from the market. Results There was a good linear in the range of 0. 116 4μg-0. 349 2μg（r=0. 999 7,n=5）. The average recovery and precision （RSD ）were 97.90% and 2.83%, respectively. None of five samples uniformity conformed to the standard of Chinese pharmacopoeia. Conclusion This method was simple, accurate and provided a reference for improving production process of Ganteling Capsules.
出处
《现代中药研究与实践》
CAS
2005年第5期41-43,共3页
Research and Practice on Chinese Medicines
