Quality-By-Design Approach to Stability Indicating RP-HPLC Analytical Method Development for Estimation of Canagliflozin API and Its Validation

摘要

Context: Stability Indicating RP-HPLC analytical method validation for estimation of Canagliflozin API have been reported, but there are not studies related to the application of Analytical Quality by Design (AQbD) concepts to the development of a comprehensive science and risk based stability indicating RP-HPLC Analytical method for the analysis of Canagliflozin Active Pharmaceutical Ingredient (API). Aims: Development of a comprehensive science and risk based stability indicating RP-HPLC Analytical method for the analysis of Canagliflozin Active Pharmaceutical Ingredient (API) according to Analytical Quality by Design (AQbD) concept. Methods: AQbD key tools - identification of ATP (Analytical Target Profile), CQA (Critical Quality Attributes) with risk assessment, Method Optimization and Development with DoE, MODR (method operable design region), Control Strategy, AQbD Method Validation, and Continuous Method Monitoring (CMM) ware studied. An efficient experimental design based on systematic scouting of all key components of the RP-HPLC Analytical method (e.g. Diluents, λ max, Column and mobile phase composition) ware presented. The final method was validated according to ICH validation guideline. Results: The method was linear. (r2=0.999). The accuracy was 99% to 101%. The precision, ruggedness and robustness values were also within the prescribed limits (<1%). Conclusion: This result indicated that a consistent, reliable and cost effective method is developed for the routine analysis of Canagliflozin in quality control laboratories.