LC-MS/MS法分析复方缬沙坦氨氯地平片中的有关物质

Identification of the related substances in valsartan amlodipine tablets by LC-MS /MS

目的采用LC-MS/MS法对复方缬沙坦氨氯地平片中有关物质进行定性分析。方法采用Thermosyncronis C18色谱柱(250mm×4.6mm,5μm),以20mmol/L的醋酸铵溶液-乙腈为流动相进行梯度洗脱。采集有关物质的PDA谱、质谱母离子及子离子谱,并进行解析,推测有关物质的结构。结果在所建立的条件下,复方缬沙坦氨氯地平片中有关物质分离良好,检测出11个有关物质。结论本文建立的LC-MS/MS法可有效地分离分析复方缬沙坦氨氯地平片中的有关物质,并为其质量控制和工艺优化提供了技术参考。

Objective To establish the identification of the related substances in valsartan amlodipine tablets by LC-MS/MS method. Methods High pressure/performance liquid chromatography （HPLC） separation was carried out on Thermo syncronis C column （250 mm×4.6mm,5μm） with a gradient elution with a mobile phase consisting of 20 mmol/L ammonium acetate and pure acetonitrile. The PDA,parent ions and the corresponding product ions spectra of all the related substances in valsartan amlodipine tablets were determined. Results Good resolution of valsartan and amlodipine and their main related substances were achieved. Eleven related substances in valsartan amlodipine tablets were detected by LC-MS/MS. Conclusion The established method is effective in the separation and identification of the related substances in valsartan amlodipine tablets and the results are useful for its quality control.