| 引用本文: | 谢升谷,陈爽,郑国钢.HPLC测定注射用甘草酸二铵18位异构体及其比值考察[J].中国现代应用药学,2013,30(7):772-775. |
| XIE Shenggu,CHEN Shuang,ZHEN Guogang.HPLC Determination of 18-isomer of Diammonium Glycyrrhetate for Injection and Its Ratio Evaluation[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(7):772-775. |
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| 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。 |
| 关键词: 注射用甘草酸二铵 异构体 高效液相色谱法 |
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| HPLC Determination of 18-isomer of Diammonium Glycyrrhetate for Injection and Its Ratio Evaluation |
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XIE Shenggu, CHEN Shuang, ZHEN Guogang
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Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
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| 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. |
| Key words: diammonium glycyrrhetate for injection epimer HPLC |
