Determination on Vildagliptin in Rat Plasma by Capillary Electrophoresis Tandem Mass Spectrometry: It’s Application to Pharmacokinetic Study

Abstract:

Background: Vildagliptin, a dipeptidyl peptidase-4 inhibitor, is one of the potent oral antidiabetic agent. Objective: The objective of the present work was to establish a rapid, sensitive and validated capillary electrophoresis Quadrupole Time-of-flight Mass Spectrometry method from rat plasma. Methodology: Vildagliptin was estimated in rat plasma after precipitation of plasma proteins by acetonitrile, using sitagliptin as internal standard. For separation of vildagliptin from plasma components, fused silica capillary with background electrolyte consisting of 0.25 mM ammonium formate buffer, with SL composition of 50:50 methanol and water consisting of 0.25% of formic acid, pumped at a flow rate of 0.2 ml/min was used. Electron spray ionization with positive ion multiple reaction mode was applied for detection of analytes. Results: Newly developed method showed good calibration curve in the concentration range of 1 – 500 ng/ml with excellent correlation coefficient (r²>0.998). The detection limit of the method was found to be 0.31 ng/ml and percent assay was above 93%. The percent coefficient of variations for both intraday and interday were less than 9%. Conclusion: The newly developed and validated CE MS/MS method was effectively utilized for pharmacokinetic studies in rats after oral administration of vildagliptin.

Key words: Vildagliptin, CE, Mass Spectrometry, Validation, Plasma, Pharmacokinetics.