The Review: Development And Validation Of Rphplc Method For Simultaneous Estimation Of Ertugliflozin And Metformin In Pharmaceutical Dosage Form.

The accurate and efficient estimation of pharmaceutical compounds is critical in ensuring the quality and safety of medications.Ertugliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, and Metformin, a widely used biguanide, are frequently combined in the treatment of type 2 diabetes mellitus for improved glycemic control.The development and validation of a robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of these drugs in pharmaceutical dosage forms is essential for quality control and regulatory compliance.This review focuses on the principles, methodology, and outcomes associated with the RP-HPLC technique employed for the simultaneous quantification of Ertugliflozin and Metformin.The study explores the optimization of chromatographic conditions, including the selection of the mobile phase, column, flow rate, and detection wavelength, to achieve precise and accurate separation of both analytes.The method development process emphasizes achieving optimal resolution, peak symmetry, and retention time.Validation of the developed method is performed following the guidelines of the International Council for Harmonisation (ICH).Key parameters such as specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness are systematically assessed.The method demonstrates excellent linearity over a specific concentration range for both analytes, with correlation coefficients exceeding acceptable limits.Precision studies reveal consistent repeatability and intermediate precision, while robustness testing confirms the method's reliability under varied analytical conditions.The RP-HPLC method described offers a rapid, cost-effective, and reliable approach for the routine quality control of pharmaceutical formulations containing Ertugliflozin and Metformin.The results indicate its suitability for application in pharmaceutical industries and research laboratories for the simultaneous estimation of these drugs in combined dosage forms.Furthermore, the study highlights potential challenges and solutions in method development and validation, contributing to the advancement of analytical methodologies in pharmaceutical analysis.In conclusion, the developed RP-HPLC method is a significant contribution to the field of analytical chemistry, providing a validated protocol for the simultaneous quantification of Ertugliflozin and Metformin in pharmaceutical preparations.The robustness and reliability of the method ensure its utility in routine quality assurance and compliance with regulatory standards.This review aims to provide a comprehensive overview of the RP-HPLC method's development, validation, and application, addressing the critical need for efficient analytical methods in the pharmaceutical sector.