Development and Validation of A RP-HPLC-PDA Method for Simultaneous Determination of Linagliptin and Metformin in Pharmaceutical Dosage Form

Abstract

A simple, accurate, precise, and stability-indicating reverse phase high-performance liquid chromatographic (RP-HPLC) method with photodiode array (PDA) detection was developed and validated for the simultaneous determination of Linagliptin and Metformin in pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column with an optimized mobile phase composition under isocratic conditions at a suitable flow rate. Detection was carried out using a PDA detector at an optimized wavelength, providing well-resolved and symmetrical peaks for both analytes within a reasonable run time.

The developed method was validated in accordance with ICH Q2(R1) guidelines. The method demonstrated good specificity with no interference from excipients. Linearity was observed over the selected concentration ranges with correlation coefficients close to unity. The method showed satisfactory accuracy, with percentage recovery within acceptable limits. Precision studies indicated low %RSD values, confirming repeatability and intermediate precision. The limits of detection (LOD) and quantification (LOQ) indicated adequate sensitivity of the method. Robustness studies revealed that small deliberate variations in chromatographic conditions did not significantly affect the results.

The validated method was successfully applied to the quantitative analysis of Linagliptin and Metformin in marketed tablet formulations. The results were found to be within acceptable limits of the labelled claim, confirming the suitability of the method for routine quality control analysis.