Development and validation of selective and sensitive liquid chromatography - Tandem mass spectroscopy (UHPLC-MS/MS) method for bioanalysis of remogliflozin in rat plasma

Remogliflozin is an inhibitor of sodium-glucose cotransporter 2 inhibitors (SGLT-2) protein and plays an important role in the treatment and management of type-2 diabetes mellitus. In this study, a selective isocratic method was developed and validated using liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) for the determination of remogliflozin in rat plasma. Acetonitrile with formic acid was used as a precipitating agent. Chromatographic separation was achieved by using X select CSH Fluorophenyl (150 mm × 4.6 mm, 3.5 μm) column and 0.1% formic acid in milli-Q water (20%) and acetonitrile (80%), v/v as a mobile phase for isocratic elution method. Flow rate and injection volume were maintained at 0.7 mL/min and 10 μL, respectively. The validated method was linear in the range of 15– 2009 ng/mL with the lower limit of quantification (LLOQ) of 18 ng/mL. Also, the method was precise with a % CV less than 5.75 and accuracy within ±10% of nominal concentration. The method is accurate, simple, precise, and suitable for its application in further bioequivalence and pharmacokinetic studies.