RP-HPLC法测定伪麻那敏缓释胶囊中的有效成分及释放度

Ingredients and dissolution of psuedoephedrine hydrochloride and chlopheniramine maleate sustained-release capsules by RP-HPLC

目的 建立伪麻那敏缓释胶囊中盐酸伪麻黄碱和马来酸氯苯那敏分析方法,测定进口和自制伪麻那敏缓释胶囊的体外释放度。方法 RP-HPLC法用苯基柱,流动相为甲醇-磷酸缓冲液(60:40),检测波长为254 nm。结果 盐酸伪麻黄碱在5.78-723.00 μg·mL-1线性关系良好(r=1.000),马来酸氯苯那敏在0.41-51.00μg·mL-1线性关系良好(r=1.000)。样品的回收率分别为100.4％(RSD=1.1％,n=15)和98.7％(RSD=1.6％,n=15)。结论 采用RP-HPLC法控制产品质量准确、迅速,累计释放曲线符合一级方程:ln(1-Mt/M∞)＝-kt。

OBJECTIVE To develop a method to determine psuedoephedrine hydrochloride and chlopheniramine maleate sustained-release capsules. METHODS RP-High-pressure liquid chromatography was performed on a Phenyl 3 column with mobile phase of methanol - phosphate buffer (60 : 40) . The monitoring wavelength was 254 nm. RE SULTS The linear ranges were 5. 78-723. 00 μg · mL-1 (r=1. 000) and 0. 41-51. 00 μg · mL-1(r= 1.000), and the recoveries were 100. 4% (RSD=1. 1%, n=15) and 98. 7% (RSD=1. 6%, n=15) for psuedoephedrine hydro chloride and chlopheniramine maleate, respectively. CONCLUSIONS This method is accurate,sensitive, rapid and can be used to control the quality of psuedoephedrine hydrochloride and chlopheniramine maleate sustained-release cap sules. The accumulative release of the drug matches one degree model: In (1-Mt/M∞) =-kt.