Bioanalytical Method Development and Validation for the Estimation of Metformin and Vildagliptin in K3EDTA Human...

Area of Science:

• Analytical Chemistry
• Pharmacokinetics

Background:

• Metformin and vildagliptin are commonly prescribed antidiabetic drugs.
• Accurate quantification of these drugs in biological matrices is crucial for pharmacokinetic and bioequivalence studies.

Purpose of the Study:

• To develop and validate a sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for determining metformin and vildagliptin concentrations in human plasma.
• To ensure the method meets USFDA bioanalytical guidelines for reliability in clinical research.

Main Methods:

• A Cosmosil CN column was used for chromatographic separation with an isocratic mobile phase.
• Detection was performed using an electrospray ionization mass spectrometer in positive ion mode and multi-reaction monitoring (MRM).
• Solid phase extraction (SPE) was employed for sample preparation, utilizing metformin-D6 and vildagliptin-D7 as internal standards.

Main Results:

• The method achieved good extraction recoveries for both metformin (89.44%) and vildagliptin (92.26%).
• Linear calibration curves were established with high correlation coefficients (r² > 0.99) across specified ranges (0.5-400 ng/mL for metformin, 0.2-160 ng/mL for vildagliptin).
• Short retention times of 3.2 and 3.8 minutes for metformin and vildagliptin, respectively, indicate efficient analysis.

Conclusions:

• The developed LC-MS/MS technique is reliable and efficient for the quantification of metformin and vildagliptin in human plasma.
• This method is suitable for monitoring bioequivalence studies and other clinical investigations involving these antidiabetic agents.