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

关键词:  注射用甘草酸二铵  异构体  高效液相色谱法

Key words:  diammonium glycyrrhetate for injection  epimer  HPLC

摘要:

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-α GL和18-β GL)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。

Abstract:

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 C₁₈ 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.