格列喹酮片有关物质测定方法研究

目的 建立HPLC法测定格列喹酮片有关物质测定的方法.方法 采用C18(4.6 mm×250 mm,5 μm)色谱柱,磷酸二氢铵溶液(pH=3.5)-乙腈(3:5)为流动相,检测波长230 nm.结果 格列喹酮在0.005～0.1 g·L-1 (r=0.999 4)范围内、已知杂质异喹啉物在0.001～0.05 g·L-1 (r=0.999 9)范围内线性关系良好;格列喹酮平均回收率为100.1%,RSD=0.39%(n=9),异喹啉物平均回收率为100.3%,RSD=0.38%(n=9).结论 该法较中国药典2010年版格列喹酮片有关物质测定方法,灵敏度更高,能更好的控制格列喹酮片有关物质质量.

Determination of the related substances of Gliquidone Tablets

Objective To establish an HPLC method for determination of the related substances of Gliquidone Tablets.Methods A C18 column was used,ammonium dihydrogen phosphate solution-acetonitrile（3：5） as mobile phase with UV detection at 230nm.Results The calibration curve was in good linearity over the range between 0.005 and 0.1 g·L-1（r=0.999 4,Gliquidone） and from 0.001 to 0.05 g·L-1（r=0.999 9,isoquinoline impurity）.The average recovery was 100.1%（n=9,RSD=0.39%,Gliquidone） and 100.3%（n=9,RSD=0.38%,isoquinoline impurity）.Conclusion The method is accurate and can be used for the quality control of Gliquidone Tablets.