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The simultaneous quantification of Sitagliptin and Irbesartan in rat plasma using the validated LC-MS/MS method is applied to a pharmacokinetic study.

P. Divya Bhargavi,Siddhartha Lolla,Sinoy Sugunan,Kumar Shiva Gubbiyappa,Azmat Ali Khan,A. Alanazi,Bhukya Vijay Nayak

Published 2023 in Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

ABSTRACT

Irbesartan (IRB), an angiotensin II receptor AT1 blocker, is an antihypertensive agent commonly used with Sitagliptin (STG), a novel antidiabetic agent in diabetes. A finalised and validated LC-MS/MS method was used for the bioanalytical quantification of STG and IRB to be applicable to studies on the P.K drug-drug interactions between STG and IRB. Using a YMC triart C18 column (50 mm × 4.6 mm i.d., 3 µm), both the drugs and the Tolbutamide were separated using a gradient mode with a flow rate of 1 ml/min with run time of 5 min. For analyte detection, an LC-MS/MS system with multiple reaction monitoring (MRM) was used. The technique was validated across a concentration range of 5-1000 ng/ml, with the LLOQ for both analytes being 5 ng/ml. At all QC levels accuracies from spiked samples were > 83% for both drugs and internal standards. The accuracy for STG within-batch and between-batch was found within 98.4-107.2%, and for IRB was found within 92.4-102.5%. The precision for STG within batch and between batches was less than 12.3% CV, and for IRB was less than 10.2% CV at all concentration levels. The pharmacokinetic profiles of STG and IRB were successfully applied on simultaneous oral administration to rats. This method applies to pharmacokinetic multidrug interaction studies.

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