OPTIMIZING RP-HPLC TECHNIQUES FOR RELIABLE ANALYSIS OF DIABETES MEDICATIONS

Abstract

Introduction: A robust and precise RP-HPLC method was developed for the simultaneous quantification of Metformin, Vildagliptin, and Remogliflozin in pharmaceutical formulations, essential for managing Type 2 Diabetes Mellitus (T2DM). Utilizing the Analytical Quality by Design (AQbD) approach, critical parameters like flow rate, organic phase ratio, and temperature were optimized to enhance robustness, efficiency, and adaptability. The method strictly adheres to ICH Q2(R1) validation guidelines, ensuring reliability through rigorous validation of linearity, precision, accuracy, and reproducibility. This optimized RP-HPLC method provides a high-performance, regulatory-compliant solution for pharmaceutical quality control and diabetes treatment safety.
Objectives: The objective is to develop a precise and reliable RP-HPLC method for the simultaneous quantification of Metformin, Vildagliptin, and Remogliflozin in pharmaceutical formulations. Using the AQbD approach, critical chromatographic parameters were optimized to enhance robustness and efficiency. The method was validated per ICH Q2(R1) guidelines, ensuring accuracy, precision, and reproducibility. This optimized method is suitable for routine pharmaceutical quality control, ensuring regulatory compliance and the safety of diabetes treatments.
Methods: A robust RP-HPLC method was developed for the simultaneous quantification of Metformin, Vildagliptin, and Remogliflozin using the Analytical Quality by Design (AQbD) approach. Critical method parameters such as flow rate, organic phase ratio, and temperature were systematically optimized to enhance method robustness and efficiency. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of a precisely optimized combination of an organic modifier and buffer solution. The method was validated following ICH Q2(R1) guidelines, assessing linearity, precision, accuracy, specificity, and reproducibility under different conditions.
Results: The optimized RP-HPLC method demonstrated excellent resolution and peak symmetry for all three drugs, ensuring precise and accurate quantification. Linearity was confirmed within the established concentration range, with correlation coefficients (R²) exceeding 0.999. Precision studies showed a low %RSD, indicating method consistency. Accuracy results confirmed high recovery rates, while robustness testing validated its adaptability across varying conditions. The method successfully quantified Metformin, Vildagliptin, and Remogliflozin in pharmaceutical formulations without interference from excipients.
Conclusions: The developed RP-HPLC method is a highly reliable, accurate, and regulatory-compliant analytical technique for the simultaneous estimation of Metformin, Vildagliptin, and Remogliflozin. By integrating AQbD principles, this method ensures precision, efficiency, and robustness, making it suitable for routine pharmaceutical quality control and contributing to the safety and efficacy of diabetes treatments.