复方银翘氨敏胶囊中维生素C与对乙酰氨基酚的溶出度测定

Dissolution Determination of Vitamin C and Paracetamol in Compound Yinqiao and Paracetamol and Chlorphenamine Maleate Capsules

目的建立复方银翘氨敏胶囊中维生素C与对乙酰氨基酚的溶出度测定方法。方法采用篮法,以900mL0. 1mol·L-1盐酸溶液作为溶出介质,转速为100r·min-1,以高效液相色普法测定。采用C18柱,以甲醇-乙腈-0. 02%磷酸溶液(5∶10∶85)为流动性,检测波长为219nm。结果维生素C与对乙酰氨基酚分别在浓度24. 32~145. 9μg·m L-1和50. 38~302. 3μg·m L-1范围内呈良好的线性关系,平均回收率分别为99. 1%、98. 9%,RSD分别为0. 5%、0. 9%。样品溶出均一性好,在45min时6片中维生素C与对乙酰氨基酚的溶出度均达到了90%以上。结论本方法快速、简便、结果准确,可作为该制剂中维生素C与对乙酰氨基酚的溶出度的测定方法。

OBJECTIVE To extablish a HPLC for dissolution determation of vitamin C and paracetamol in compound Yinqiao and Paracetamol and Chlorphenamine Maleate Capsules. METHODS Basket method was used,with 0.1mol·L ^-1 HCL as the dissolution medium,speed of 100r·min -1 ,measured byhigh performance liquid chromatography.C 18 column was used with a mobilephase of methanol-acetonitrile-0.02% phosphoric acid solution （5∶10∶ 85）.The detective wavelength was 219nm. RESULTS The standard curves of vitamin C was good in the range of 24.32-145.9μg·mL^ -1 .The standard curves of paracetamol was good in the range of 50.38-302.3μg·mL^ -1 .The average recovery of vitamin C was 99.1%（RSD=0.5%） and paracetamol was 98.9%（RSD=0.9%）.The homogeneity of sample dissolution was good.The dissolution rate of vitamin C and acetaminophen in 6 tablets reached more than 90% at 45min.CONCLUSION The method is rapid,simple and accurate for dissolution determination of vitamin C and paracetamol in compound Yinqiao and Paracetamol and Chlorphenamine Maleate Capsules.