A HILIC-MS/MS assay for the quantification of metformin and sitagliptin in human plasma and urine: A tool for studying drug transporter perturbation.

This article describes the development and validation of a HILIC-MS/MS method for the simultaneous quantification of metformin and sitagliptin from human plasma and urine. The presented method uses quick sample preparation and fast chromatography allowing for high sample throughput. The quantification is performed using multi-reaction monitoring and ESI positive mode with stable isotope labelled internal standards for both metformin and sitagliptin. Excellent linearity in the selected calibrations ranges, low inter-day variability (CV% <6.7%), and high accuracy (95.5-104.1%) were obtained. Adequate retention was attained for both analytes by hydrophilic interaction liquid chromatography using a plain silica column in combination with a mobile phase composed of ammonium formate, acetonitrile, formic acid and water in gradient separation mode.