Analytical Method Development and Validation of Trelagliptin by RP-HPLC

Abstract

Aim: The aim of the present study was to develop and validate a simple, rapid, precise, and robust RP-HPLC method for the quantitative estimation of Trelagliptin in pharmaceutical analysis. Materials and Methods: Chromatographic separation was achieved using RP-HPLC under optimized isocratic conditions with UV detection. The developed method was validated according to ICH Q2 (R2) guidelines for various analytical parameters including linearity, accuracy, precision, robustness, Limit of Detection (LOD), and Limit of Quantification (LOQ).

Results: The method showed excellent linearity over the selected concentration range with a correlation coefficient (r²) of 0.999. The intra-day and inter-day precision studies showed low %RSD values of 0.12% and 0.26%, respectively, indicating good repeatability and reproducibility. Accuracy studies demonstrated satisfactory recovery within acceptable limits. Robustness testing showed a %RSD value of 1.41%, confirming that minor variations in analytical conditions did not significantly affect the method performance. The LOD and LOQ were found to be 1.53 µg/mL and 4.63 µg/mL, respectively. System suitability parameters were within acceptable limits. Conclusion: The developed RP-HPLC method was found to be sensitive, accurate, precise, reliable, and suitable for routine quality control and quantitative estimation of Trelagliptin in pharmaceutical analysis.