柱后衍生化HPLC法测定前列地尔乳剂的有关物质

目的：建立测定前列地尔乳剂中有关物质前列腺素A1含量的方法。方法：采用C18色谱柱,磷酸盐缓冲液-乙腈（2∶1,V∶V）为流动相,β-萘酚为内标,氢氧化钾溶液为柱后衍生液,流速：1.0 ml/min,检测波长：278 nm。结果：前列腺素A1在0.5～10.0μg/ml浓度范围内线性关系良好（r=0.999 7）,精密度试验的RSD为1.0%,重复性试验的RSD为1.2%,平均回收率为100.1%,RSD为1.1%（n=9）。结论：该法适用于前列地尔乳剂中前列腺素A1的检测。

Determination of the related substances in Alprostadil emulsion by HPLC with Post-Column derivatization

Objective：To establish the analytical method for Prostaglandin A1 in the Alprostadit Emulsion.Methods：C18 column was used.The mobile phase consisted of phosphate buffer,acetonitrile（2∶1,V∶V）.β-naphthol was used for internal standard substances.The past column reaction solution was potassium hydroxide solution.The flow rate was 1.0 ml/min.The detection wavelength was at 278 nm.Results：The calibration curve of Prostaglandin A1 was linear（r=0.999 7） within the range of 0.5-10.0 μg/ml.The RSD of precision was 1.0%.The RSD of repetitiveness was 1.2%.The average recovery rate were 100.1% with a RSD of 1.1%（n=9）.Conclusion：The method can be used for the quality control of Prostaglandin A1 in the A1 prostadil Emulsion.