LC-MS／MS法测定前列地尔注射液中前列腺素A1

目的：建立高效液相色谱一四极杆串联质谱联用法（LC-MS／MS法）测定前列地尔注射液中前列腺素A1的含量。方法：前列地尔注射液经稀释后，采用Agilent．poroshell120SB—C18色谱柱（2．1×50mill，2．7μm）进行分析，流动相为乙腈-0．5％甲酸水溶液，流速0．2mL／min；质谱采用电喷雾离子化（ESI）源，负离子-多反应监测（MRM）模式，内标法定量。结果：前列腺素A1的线性范围为0．3—10ng／mL；平均回收率为100．2％，RSD为1．69％。3批样品每1mL中含前列腺素A1均来过3．0μg。结论：该方法准确、简单、快速，可用于前列地尔注射液中前列腺素A1的测定。

Determination of Prostaglandin A1 in Alprostadil injection by LC-MS/MS

Objective： To establish a liquid chromatography-tandem mass spectrometric method（LC- MS/MS） for the determination of Prostaglandin A1 in Alprostadil injection. Methods： After being diluted,the sample was separated on an Agilent.poroshell 120 SB-C18 column（2.1×50 mm 2.7 μn） for isocratic elution with a mobile phase of acetonitrile-0.5% formic acid water- solution at a flow rate of 0.2 mL/min.Then the processed sample was analyzed by tandem mass spectrometer with negative- electrospray ionization（ESI） source,monitored under a multiple reaction monitoring（MRM） mode. Results： The calibration curve showed a good linearity in the range of 0.3 -10 ng/mL.The average recovery was 100.2% with RSD of 1.69%.The content of Prostaglandin At in batches of Alprostadil injection samples was not more than 3.0 μg/mL. Conclusion： The developed method can be used for the quantitative determination of for Prostaglandin A1 in Alprostadil injection.