54-Vol.-12-Issue-6-June-2021-IJPSR-RA-14978.pdf

A simple, sensitive, and fast single-step extraction method for estimating empagliflozin in human plasma using LC-MS/MS was developed and validated for pharmacokinetic evaluations. Plasma samples were basified before undergoing solid-phase extraction using SOLA cartridges. Chromatographic separation was achieved on a Hypersil BDS C18 column with a 3.5-minute run time. Quantification was performed using a single SRM transition (m/z: 449.140 → 371.100) in negative ion mode over the range of 1.563–800.000 ng/mL. The method met all USFDA validation criteria for selectivity, matrix effect, recovery, stability, and precision, making it suitable for routine bio-analytical applications in preclinical, toxicology, and PK/PD studies.<b>DOI:</b> 10.13040/IJPSR.0975-8232.12(6).3457-63