Development and validation of an lc-ms/ms method for determination of tigecycline and its epimer in human plasma and its application in a pharmacokinetic study

Abstract

A rapid, selective, sensitive, and simple method for simultaneous determination of tigecycline and its epimer in human plasma samples was developed and validated by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Sample preparation involved one-step protein precipitation by adding 0.1% formic acid-methanol and phosphate buffer (PB) solution to the plasma. Chromatographic separation was obtained with XBridge BEH C18 column (3.5 ?m, 50 × 4.6 mm) through a 9.5-min gradient mobile phase at the flow rate of 0.6 mL min-1 at 4 °C. The calibration curves were linear over concentration 5.00-2000 ng mL-1 with correlation coefficient greater than 0.998. Intra-batch and inter-batch accuracy of the assay were in the ranges of -2.90% to 3.00%, and the corresponding precision was less than 6.97%. The extraction recovery of tigecycline and its epimer with the current method were 87.2% and 76.9%, respectively. The applied LC-MS/MS method was shown to be sufficiently sensitive and will be suitable for pharmacokinetic studies.