Simultaneous Method Development and Validation of Metformin HCL and Myo Inositol by Using LC-MS/MS

An easy, quick, precise, active and reproducible Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) technique was developed for the bio analytical method of Metformin HCl and Myo-Inositol using Bexagliflozin as Internal Standard (IS). This article summarizes the recent progress on bio analytical LC-MS/MS methods using Symmetry shield RP-18 column (250x4.6 mm, 5µ) and organic mobile phase of 0.1% TEA pH-2.5/Formic acid and Acetonitrile in 60:40 v/v. Analysis was carried out within 7 minutes over a good linear concentration range from 1.0ng/mL to 40.0ng/mL (r2 = 0.99979± 0.005) for Metformin HCl and 1.50ng/mL to 60.0ng/mL (r2 =0.99996± 0.007) for Myo-Inositol. Accuracy, precision, recovery, matrix effect and stability results were found to be within the suitable limits. The application denotes all the parameters of system suitability, specificity, linearity and accuracy are in good agreement with United States Food and Drug Administration (USFDA) guidelines and applied effectively for the investigation of pharmacokinetic studies in rat.