高效液相色谱法同时测定复方酚咖伪麻胶囊中5种成分溶出度

Dissolution Determination of Five Compounds in Compound Paracetamol Caffeine and Pseudoephedrine Hydrochloride Capsules by HPLC

目的建立同时测定复方酚咖伪麻胶囊5种成分溶出度的高效液相色谱(HPLC)法。方法色谱柱为WatersXTerraC_(18)柱(250 mm×4.6 mm,5μm),流动相A为0.02 mol/L磷酸二氢钾溶液-三乙胺(100∶0.02,V/V)、流动相B为甲醇(梯度洗脱),流速为1.0 mL/min,检测波长为215 nm;采用篮法,转速为100 r/min,溶出介质为0.1 mol/L盐酸溶液500 mL。结果盐酸伪麻黄碱、对乙酰氨基酚、咖啡因、马来酸氯苯那敏和盐酸氯哌丁质量浓度分别在6.14~61.42μg/mL,60.62~606.23μg/mL,5.28~52.80μg/mL,0.52~5.21μg/mL,2.47~24.68μg/mL范围内与峰面积线性关系良好(r≥0.9998),精密度和稳定性试验的RSD均小于2.0%(n=6),平均加样回收率分别为100.09%,99.65%,99.67%,99.83%,99.17%,RSD分别为1.07%,1.29%,1.16%,0.98%,1.28%(n=9)。结论该方法操作简便,结果准确可靠,专属性强、可用于复方酚咖伪麻胶囊的质量控制。

Objective To establish an high-performance liquid chromatography(HPLC)method for the dissolution determination of five compounds in Compound Paracetamol Caffeine and Pseudoephedrine Hydrochloride Capsules.Methods The chromatographic column was Waters XTerra C_(18)column(250 mm×4.6 mm,5μm)with gradient elution,the mobile phase A was 0.02 mol/L potassium dihydrogen phosphate-triethylamine(100∶0.02,V/V),and the mobile phase B was methanol(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 215 nm.The dissolution was detected by basket method using 500 mL of 0.1 mol/L hydrochloric acid as solvent at rotation speed of 100 r/min.Results The linear ranges of pseudoephedrine hydrochloride,paracetamol,caffeine,chlorphenamine maleate and cloperastine hydrochloride were 6.14-61.42μg/mL,60.62-606.23μg/mL,5.28-52.80μg/mL,0.52-5.21μg/mL and 2.47-24.68μg/mL,respectively(r≥0.9998).The RSDs of precision and stability tests were less than 2.0%(n=6).The average recoveries of pseudoephedrine hydrochloride,paracetamol,caffeine,chlorphenamine maleate and cloperastine hydrochloride were 100.09%,99.65%,99.67%,99.83%,99.17%with RSDs of 1.07%,1.29%,1.16%,0.98%and 1.28%(n=9),respectively.Conclusion The method is accurate,specificity,simple,which is suitable for the quality control of the Compound Paracetamol Caffeine and Pseudoephedrine Hydrochloride Capsules.