高效液相色谱法对甘利欣注射液中18α-甘草酸及18β-甘草酸含量测定.docVIP

高效液相色谱法对甘利欣注射液中18α-甘草酸及18β-甘草酸含量测定摘 要：目的：用RP-HPLC法测定甘利欣注射液中18α-甘草酸和18β-甘草酸的含量。方法：采用ZORBAX Extend C18分析柱（4.6mm×250mm,5μm）；乙腈-磷酸盐缓冲液（pH=7：20：80）为流动相；检测波长250nm；流速1mL#8226;min-1；柱温为30℃。取混合对照品溶液及供试品溶液，分别注入液相色谱仪，以混合对照品溶液色谱图中18α-甘草酸和18β-甘草酸的峰面积（3次平均）外标法计算甘利欣中18α-甘草酸和18β-甘草酸的含量。结果：18α-甘草酸和18β-甘草酸分别在0.1010~ 1.0100μg（r=0.99984）和0.1033~1.0330μg（r=0.99948）范围内呈线性；18α-甘草酸和18β-甘草酸加样回收率和RSD分别为98.02%、RSD=0.35%和97.5%、RSD=0.54%。结论：对于提高甘利欣注射液药品质量标准，该方法更加简便、可靠、准确，具有定性、定量双重意义。? 关键词：甘利欣；18α-甘草酸；18β-甘草酸；RP-HPLC；含量测定? 中图分类号：R284.1文献标识码：A 文章编号：1673-7717(2008)11-2512-03?? Determination of 18α-Glycyrrhizic Acid and 18β-Glycyrrhizic Acid in ? Diammonium Glycyrrhizinate Injection by RP-HPLC ?? LIU Jin?cheng?1,HANG Qing?2,ZHANG Ding?shan?2? (1.The Sixth People’s Hospital of Hangzhou,Hangzhou 310014,Zhejiang,China;?2.Precaution and Health Maintenahce Department of Hangzhou,Hangzhou 310014,Zhejiang,China)?? Abstract:Objective: To determine the contents of 18α-glycyrrhizic acid and 18β-glycyrrhizic acid in Diammonium Glycyrrhizinate Injection by RP-HPLC. Methods:The Chromatographic method was carried out on ZORBAX Extend C18 column using acetonitrile-phosphate buffer solution(pH=7∶20∶80 ) as a mobile phase. The detection wavelength at 250nm.The flow rate was 1mL#8226;min-1.The column temperature was 30℃. Took control solution mixture and experimental solution,poured in chromatograph of liquid respectively, with peak area external reference method of 18α-glycyrrhizic acid and 18β-glycyrrhizic acid in control solution mixture chromatogram, to determined the contents of 18α-glycyrrhizic acid and 18β-glycyrrhizic acid.Results:The 18α-glycyrrhizic acid and 18β-glycyrrhizic acid calibration curves were linear at the of 0.1010~ 1.0100μg（r=0.99984）and 0.1033~1.0330μg（r=0.99948）.The average recoveries were 98.02% with RSD 0.35% for 18α-glycyrrhizic acid and 97.5% with RSD 0.54% for 18β-glycyrrhizic acid.Conclusion:This method is simple, reliable and provides a reference standard fo