Implementation of Quality by Design (QbD) approach to the analytical method development and validation for the estimation of Remogliflozin Etabonate in tablet dosage form by HPLC

Abstract

Analytical Quality by Design is a recent concept related to the development and validation of the analytical procedures (AQbD). This is done in analytical QbD by defining quality targets which enable the performance of the analytical procedure within the MODR. This is because AQbD considers Out Of Trend (OOT) and out of specification (OOS) results by the quality of the procedure. Therefore, the QbD approach to analytical development is preventative, systematic, and is based on risk which greatly assists in understanding how differences in CPPs impact on CQAs. Thus, DoE plays a crucial role in QbD, for executing the response surface analysis and the screening process, and finally for defining the area with several dimensions of the successful operating ranges of the CPPs, supposed as Design Space (DS).

The objectives of this paper are to describe the development and validation of a rapid, sensitive and specific RP-HPLC method for the determination of Remogliflozin etabonate in its bulk drug and tablet dosage forms. In this method Column with mobile phase Methanol: Water (90:10) was applied in the enhancement of the method. For Remogliflozin etabonate the retention time at the wavelength of 225 nm was 4.48 min to complete and meets the ICH guidelines in the aspects of accuracy, linearity, precision, robustness, LOD, and LOQ.