Determination of erlotinib in human plasma by HPLC-MS/MS

Objective To develop a liquid chromatography-tandem mass spectrometry to determine erlotinib in human plasma. Methods After protein precipitation with methanol,erlotinib and internal standard were chromatographically separated on an Ultimate XB C18 column(4.6 mm×150 mm,5 μm) with the mobile phase containing(0.1% formate and 5 mmol·L-1 ammonium acetate buffer) and acetonitrile(40∶60,v/v) at 0.9 mL·min-1.The electronic spray ion tandem mass spectrum with the positive mode and multitude reaction monitor(MRM) were used to detect the analytes. Results The linear range of the calibration curves was 1-2 000 ng·mL-1 for erlotinib.The intra-and inter-day precision was less than 15%.The methodology recovery ranged from 103.5% to 109.0%. Conclusion The present method is sensitive,effective and reliable,which has been successfully used in the pharmacokinetic studies of erlotinib after oral administration in healthy Chinese volunteers.