Concurrent Estimation of Pregabalin and Etoricoxib by New Stability-Indicating RP-UPLC Approach - Application in Assay of Commercial Tablets

Abstract

Background: The study emphasizes establishing a stability-indicating RP-UPLC method for concurrent estimation of pregabalin and etoricoxib in combined pharmaceutical formulations, confirming effective separation, sensitivity, and repeatability, validated according to ICH guidelines. Objective: The present research study aims to establish a new stability-indicating RP-UPLC method for concurrently estimating pregabalin and etoricoxib in blended powder and their combined tablet formulation with less run time, high sensitivity, and specificity. Methods: The effective separation of pregabalin and etoricoxib was achieved with HSS column C18 (150x2.1mm,1.8μm), 0.1% orthophosphoric acid:acetonitrile (65:35 v/v) at a flow rate of 0.3mL/min, and isocratic elution at 228nm. The elution of PRB and ETB was noticed at 1.56 and 2.01 minutes, with good resolution and system suitability with the developed approach. Results: Pregabalin and etoricoxib have shown linear responses from 18.75 to 112.5μg/mL and 15 to 90μg/mL, respectively. The range of the % RSD for intraday and inter-day precision was 0.33 to 0.81. The LOD and LOQ of pregabalin and etoricoxib were computed to be 0.07 μg/mL and 0.21 μg/mL, and 0.01μg/mL and 0.04 μg/mL, respectively, by standard deviation method. The validation method was carried out using ICH standards. The stability-indicating feature of the method was confirmed by the forced degradation studies where degradants generated by stress testing were clearly distinguished from the peaks of analytes. Conclusion: The shorter elution period and superior sensitivity of both analytes with this method have been found to be appropriate for regular analysis of pregabalin and etoricoxib.