高效液相色谱法测定伊格列净片剂的含量

A high performance liquid chromatography method to determine the content of igligliflozin tablets

建立高效液相色谱法测定伊格列净片剂含量的方法。使用Waters Symmetry Shield RP18(3.5μm,3.0×50mm)色谱柱,0.05%磷酸水溶液-甲醇(65:35)作为流动相,紫外检测器检测波长230nm,流速1.2mL/min,进样量20μL,进行试验分析。伊格列净与辅料峰能得到有效分离,在10.06~100.56μg/mL浓度范围内伊格列净线性关系良好,伊格列净平均回收率(n=9)为99.9%,RSD为0.3%。该方法简便快捷,准确灵敏,可用于伊格列净片剂的含量检测。

A high performance liquid chromatography method to determine the content of Igligliflozin tablets,is described.An Waters Symmetry Shield RP18(3.5μm,3.0×50mm)and 0.05%phosphoric acid aqueous solution-methanol(65:35)as mobile phase.The UV detector wavelength is 230nm.The flow rate is 1.2mL/min.The injection volume is 20μL.Igligliflozin and excipient peaks can be effectively Novarated by this method.Good linearity of Igligliflozin was obtained within the range of 10.06~100.56μg/mL.The average recovery of Igligliflozin(n=9)was 99.9%and the RSD is 0.3%.This method is simple,fast,accurate and highly sensitive,which can be used for the detection of content detection of Igligliflozin tablets.