HPLC测定注射用甘草酸二铵18位异构体及其比值考察

HPLC Determination of 18-isomer of Diammonium Glycyrrhetate for Injection and Its Ratio Evaluation

目的建立高效液相色谱法测定注射用甘草酸二铵18位异构体的方法并考察评价55批样品的异构体比值情况。方法采用C18色谱柱进行分离测定,以磷酸盐缓冲盐(pH 7.0)-乙腈(80∶20)为流动相,流速1.0 mL.min 1,测定波长252 nm。结果 18-α与18-β甘草酸二铵(18-αGL和18-βGL)分离度良好,不同厂家产品的异构体比值差异较大。结论本方法可方便、准确、可靠的测定注射用甘草酸二铵或其他甘草酸类制剂中异构体比值,其比值可能与甘草酸单铵转换为二铵盐时的工艺条件有关。

OBJECTIVE A HPLC method was established for the determination of 18-epimer of diammonium glycyrrhetate for injection,and its ratio in 55 batches products was evaluated.METHODS A C 18 column was used as the stationary phase with acetonitrile-phosphate buffering solutoion（pH 7.0）（20∶80） as the mobile phase,flow rate was 1.0 mL.min 1,and the detection wavelength was at 252 nm.RESULTS The separation of 18-α and 18-β GL was good,and the ratios of α/β were different between products.CONCLUSION The method can accurately determine ratios of α/β GL in diammonium glycyrrhetate for injection,its ratio may be related with its manufacturing process.