A Quality by Design (QbD) Based Method Development and Validation of a High-Performance Liquid Chromatography for the Simultaneous Estimation of Metformin and Ertugliflozin

Abstract

This study explains about the Analytical Quality by Design approach for the optimization of a High-Performance Liquid Chromatography Method for the simultaneous estimation of Metformin and Ertugliflozin in pharmaceutical substance. The study aimed to optimize the High-Performance Liquid Chromatography (HPLC) by means of an analytical target profile in order to achieve good separation of compounds along with acceptable analysis time. Identification of risk factors for variables affects the method efficacy. This leads to the development of an accurate, precise, and economic method. The optimized conditions of the developed method were a stationary phase of a Discovery C18 250 x 4.6mm, 5m and a mobile phase of Orthophosphoric acid buffer (pH 2.2),ACN taken in the ratio 60:40 was selected as mobile phase and detection wavelength of 230nm. The flow rate was selected as 0.98ml/min at 29.150C column temperature. Using the central composite design (CCD) method was optimized. The method is showing the linearity over the concentration range of 25-150µg/ml for Metformin and 0.375-2.25µg/ml for Ertugliflozin. The intra-and inter-day precision were less than 2% of relative standard deviation. Accuracies between 99-102% of the true values.The LOD obtained for Metformin and Ertugliflozin were found to be 59 and 3.7, respectively. LOQ obtained for Metformin and Ertugliflozin were 77.6 and 5.2, respectively.Under accelerated conditionsdegradation percentage of the drug was found to be less than 10%, and the degradation product peak not affecting the system suitability of Metformin and Ertugliflozin.