Development and validation of analytical methods for estimation of some new antidiabetic drugs in bulk and their combination using qbd approaches

Abstract

The present work represents the Method Developement and Validation of Analytical Methods for some newer Anti Diabetic drugs Dapagliflozin, Canagliflozin, Remogliflozin and Metformin HCl. Aim of present work was to develop a simple, rapid, sensitive, accurate, precise, and cost effective method for estimation of Canagliflozin, Dapagliflozin, Remogliflozin and Metformin HCl in bulk and Formulations by UV, RP HPLC and Stability Indicating method by applying Quality By Design Approach., so that it can be applied for the routine analysis of drug in Quality Control laboratories and also estimation of degradation behavior of drug By RP-HPLC. newlineFor UV Analytical Methods Shimadzu 1800 UV Spectrophotometer was used using Methanol as a Solvent. For HPLC Method Development Agilent make of HPLC is used using Phosphate Buffer, Acetonitrile, and Methanol in different Proportions as per the drug under Study. newlineFor application of QBD Approach, Design Expert®13 software was used. newlineAfter Method Development as per ICH guidelines Validation has been performed .In Linearity correlation coefficient was found to be less than 0.996. For Precision % RSD were found to be less than 1.5, which indicate that all developed methods are precise. For Accuracy % Recovery was found to be 98 % - 102%, which indicates all methods are Accurate. newlineFor HPLC, various system suitability parameters were found to be specific as per ICH guideline i.e tailing, theoretical plates, Resolution. QBD Approach was during Method Development by HPLC it helps to make all the methods Sensitive and Cost effective. After All the methods development Statistical Analysis was performed. newline newline