Development and validation of High-performance liquid chromatographic method for analysis of Polmacoxib and Paracetamol in an uncoated tablet formulation

Abstract

A simple, accurate, precise, and robust reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Paracetamol and Polmacoxib in bulk drug and pharmaceutical tablet dosage form. Chromatographic separation was achieved using a C18 Hypersil Gold column (4.6 × 250 mm) with a mobile phase consisting of 0.1% orthophosphoric acid and acetonitrile in the ratio of 60:40 v/v at a flow rate of 1.0 mL/min. Detection was carried out at 240 nm with a run time of 15 minutes. The retention time of Paracetamol and Polmacoxib was found to be 5.2 min and 12.0 min respectively, indicating good resolution between the two drugs. The developed method was validated according to ICH guidelines for parameters such as accuracy, precision, linearity, robustness, specificity, and ruggedness. The method showed excellent linearity in the concentration range of 162.5–487.5 µg/mL for Paracetamol and 1–3 µg/mL for Polmacoxib with correlation coefficients greater than 0.99. The percentage recovery for both drugs was found within acceptable limits of 98–102%, confirming the accuracy of the method. The %RSD values for precision studies were less than 2%, demonstrating good repeatability and reproducibility. The proposed RP-HPLC method was successfully applied for the quantitative estimation of both drugs in marketed tablet formulation and was found to be suitable for routine quality control analysis.