QBD-ASSISTED METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF LOBEGLITAZONE IN BULK AND ITS FORMULATION BY UV- SPECTROSCOPY

This study presents the development and validation of a UV spectrophotometric method for the estimation of lobeglitazone in bulk and pharmaceutical formulations by QbD (central composite design).Lobeglitazone, a potent anti-diabetic agent, was analyzed using UV spectroscopy due to its simplicity, cost-effectiveness, and widespread availability.Till date, there is no UV-visible spectrophotometric method reported using the AQbD approach.The method was optimized by selecting methanol as solvent, wavelength 240nm and 1.134 of maximum absorption.Validation parameters such as linearity, precision, accuracy, ruggedness, and robustness were evaluated according to ICH guidelines.The method exhibited good precision over the concentration range, with correlation coefficient values are less than 2%.The LOQ and LOD of the established method were found to be 0.83g/ml, 0.70g/ml and 2.54g/ml,2.14 g/ml.The measured linearity of the calibration curve ranges from 2 g/ml to 14 g/ml, with a R of 0.997.%RSD of system suitability, inter-day and intraday precision value of 0.11&0.14%respectively.Accuracy, with Mean recovery was found to be 100,99.6,99.2respectively for 50,100 & 150% with their %RSD values being 1.04-0.39.The robustness was evaluated for change in wavelength and results were found to be 0.17&0.23 respectively.The %RSD for ruggedness were found to be 0.26&0.18.Overall, the development of UV