HPLC测定异福双释胶囊中的有关物质

Determination of Impurity of Yifu Shuangshi Cupsules by HPLC

目的建立异福双释胶囊中的有关物质测定方法。方法采用Lichrospher 100 RP-8柱,以甲醇-乙腈-0.075mol·L-1磷酸二氢钾-1.0mol·L-1枸椽酸(30∶30∶36∶4)为流动相,检测波长为254nm。结果各种杂质与异烟肼、利福平能够很好的分离,其中醌式利福平的回收率为98.88%,N-氧化利福平的回收率为100.14%,3-甲酰利福霉素SV的回收率为97.08%。结论本方法快速、灵敏、准确,可用于异福双释胶囊的质量控制。

OBJECTIVE To establish a method for the determination of impurity of Yifu Shuangshi capsules. METHODS Liehrospher 100 RP-8 column was used in HPLC with mobile phase of methanol-acetonitrile-0. 075 mol·L^-1 potassium dihydrogen phosphate-1.0 mol·L^-1 citric acid monohydrate （ 30： 30：36 ： 4）. The detection wavelength was 254 nm. RESULTS Impurities could be separated from isonizid and rifampin in capsules. The average recoveries of quinoid rifampicin, rifampicin N-oxid and 3- formylrifamycin were 98.88% , 100.14% and 97.08% ,respectively. CONCLUSION This method is rapid,sensitive and accurate. It can be used of quality control of Yifu Shuangshi capsules.