Sensitive LC-MS/MS Method for the Simultaneous Determination ofAlogliptin and Voglibose in Human Plasma

摘要

Sensitive LC-MS/MS (Liquid Chromatography Tandem Mass Spectrometric) Method for the Simultaneous Determination of Alogliptin and Voglibose in human plasma. A highly sophisticated and sensitive LC-MS/MS method has been developed and validated for the Alogliptin and Voglibose simultaneous determination in human plasma. Alogliptin D3 and Miglitol were used as IS (Internal standard). Protein precipitation extraction was followed for the analytes and IS. Chromatography conditions included an isocratic mobile phase composing of 5 mM Ammonium formate: Acetonitrile in the ratio 50:50 v/v. The column used was Welchrom XB C18, with specifications of 50 × 4.6 mm, 5 μm, at a flow rate of 0.70 ml/min. The retention time of Alogliptin, Voglibose, Alogliptin D3 and Miglitol occurred at ~1.03, 0.8, 0.8 and 0.81 min respectively and the total chromatographic run time was 3.0 min. Alogliptin and Voglibose achieved a linear response function in human plasma at 5.09-509 ng/mL and 2.03-203 ng/mL respectively. Alogliptin and Voglibose achieved an intra and inter-day accuracy and precision in the range of 0.94- 4.35 and 0.91-3.89%; 1.41-10.8 and 1.90-7.75% respectively. The method was strictly validated according to the ICH guidelines. The results obtained from this study can be significantly utilized for developing full pharmacokinetic profiling in individuals.