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Abstract

The concept of quality by design (QbD), which entails understanding the essential components and their interaction effects by a desired set of tests, has lately gained relevance in developing analytical. To validate the simultaneous quantification of Ertugliflozin and Sitagliptin in bulk drugs and its pharmaceutical formulation, the present study discusses the development of the Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method by the QbD methodology employing the Design of Experiments. The three essential elements of the RP-HPLC method-Flow rate (ml/min), Mobile phase (%), and temperature ( o C) are systematically explored in an effective experimental design that is provided. Statistical analysis tools were used to assess the significant impact of these parameters and their interactions with the response variables (Retention time and tailing factor). The 260nm optimized wavelength was chosen. Ertugliflozin and Sitagliptin were shown to have retention times of 3.897 and 2.527 minutes, respectively. Ertugliflozin and Sitagliptin can be estimated simultaneously using a linear method over the ranges of (1.875-11.25 g/ml) and (12.5-75 g/ml), respectively. The correlation coefficient R2 for Ertugliflozin and Sitagliptin are 0.9993 and 0.9995. The method's %RSD for precision and accuracy was discovered to be under 2%. Studies on forced degradation concluded that the strategy indicated stability. Ertugliflozin and Sitagliptin both had %Recovery values of 99.81% and 99.84%, respectively. Retention time and run time decreased, so the method developed was simple and economical and can be adopted in regular Quality control test in Industries. INTRODUCTION:A Quality by Design approach is outlined as a system for planning, analyzing, and dominant manufacturing through timely measurements of essential quality and performance attributes of recent and in-process materials and processes, aiming to ensure the ultimate product safety.