ANALYTICAL QUALITY BY DESIGN APPROACH FOR DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF CANAGLIFLOZIN IN BULK AND FORMULATIONAbstract
The present work deals with the development and validation of a novel, robust, precise, and accurate UV-spectrophotometric method for the estimation of canagliflozin in bulk and formulation using the principle of Analytical Quality by Design (AQbD). A central composite design (CCD) was employed for initial parameter screening and method optimization. Different statistical parameters were evaluated to decide the appropriateness of experimental data. Canagliflozin shows an absorption maximum at 290 nm using methanol and water. Factor screening slit width and sampling interval were identified as critical method variables, which were further evaluated by a CCD. Design Expert (Version 184.108.40.206, Stat-Ease Inc., Minneapolis, MN USA) software was used for the method optimization and generation of design space Good linearity was obtained for canagliflozin in the range of 5-25 μg/mL with R2> 0.9989. The method was found to be accurate with good average % recovery. The developed method was validated as per ICH guidelines. Based on AQbD development of the Spectrophotometric method ensured that quality is built into the method. The method was robust and can be applied for determination of the canagliflozin in a pharmaceutical dosage form. The developed method was also cost-effective as it employs combination of water and methanol as solvent system.
Shraddha Parmar, Bhavna Patel * and Akshara Patel
Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar, Anand, Gujarat, India.
18 January 2021
27 April 2021
28 May 2021
01 December 2021