Application of Quality by Design Approach in Uv-Vis Spectroscopy Method Development for Simultaneous Estimation of Saxagliptin HCL and Metformin HCL in Active Pharmaceutical Ingredient

Abstract

A simple, accurate, precise and sensitive UV-Vis method has been developed for simultaneous estimation of Saxagliptin HCL and Metformin HCL in active pharmaceutical ingredient form by using quality by design (QbD) approach. A UV spectroscopic method was validated in terms of input variable effects on characteristics of UV spectrum were selected for critical parameters selection and parameters like linearity, accuracy, precision, robustness, ruggedness. The ICH guidelines Q8 to Q11 have discussed QbD implementation in API synthetic process and formulation development. Analytical QbD key tools are identification of critical quality attributes (CQA) with risk assessment, control strategy and Risk assessment, Analytical QbD method validation, continuous method monitoring (CMM) and continual improvement. The wavelength of 204.5nm and 232.5 nm are selected as absorbance maxima for Saxagliptin HCL and Metformin HCL respectively.