| 引用本文: | 刘晓岚,赫晓军,付莉,张轶华.HPLC测定注射用甘草酸二铵及其注射液的含量和有关物质[J].中国现代应用药学,2014,31(8):982-984. |
| LIU Xiaolan,HE Xiaojun,FU Li,ZHANG Yihua.Content Determination of Diammonium Glycyrrhizinate Preparation by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(8):982-984. |
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| 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。 |
| 关键词: 注射用甘草酸二铵 注射液 含量测定 有关物质 高效液相色谱法 |
| DOI： |
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| 基金项目:河北省科学技术厅项目(10276430) |
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| Content Determination of Diammonium Glycyrrhizinate Preparation by HPLC |
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LIU Xiaolan1, HE Xiaojun2, FU Li2, ZHANG Yihua2
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1.Sichuan Province Transportion Department Highway Bureau Hospital, Chengdu 611730, China;2.Hebei Institute for Drug Control, Shijiangzhuang 050011, China
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| 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. |
| Key words: diammonium glycyrrhizinate injection content determination related substance HPLC |
