HPLC测定注射用甘草酸二铵及其注射液的含量和有关物质

Content Determination of Diammonium Glycyrrhizinate Preparation by HPLC

摘要: 目的建立测定注射用甘草酸二铵及其注射液的含量和有关物质的高效液相色谱法。方法选用Agilent Extend-C₁₈柱(4.6 mm×250 mm，5 μm)；流动相：乙腈-0.01 mol·L^-1磷酸溶液(38∶62)；检测波长：252 nm；流速：1.0 mL·min^-1。结果甘草酸二铵的线性范围为12.5~1 250 μg·mL^-1(r=0.999 9)，最低检测限5.2 ng，平均回收率在99.4%以上。结论本方法专属性好，操作简便，结果准确可靠，可用于甘草酸二铵制剂的质量控制。

Abstract: OBJECTIVE To establish an HPLC method for the content determination and related substance of diammonium glycyrrhizinate preparation. METHODS Agilent Extend-C₁₈ column(4.6 mm×250 mm, 5 μm)was used with the mobile phase acetonitrile-0.01 mol·L^-1 phosphate solution(38∶62), the flow rate was 1.0 mL·min^-1, determination wavelength at 252 nm. RESULTS The linear range of the method was 12.5-1 250 μg·mL^-1(r=0.999 9), the limit of detection was 5.2 ng, the recovery of diammonium glycyrrhizinate was >99.4%. CONCLUSION The method is convenient, accurate and can be used for quality control of diammonium glycyrrhizinate preparation.