Development and Validation of a Method for Analyzing the Combination of Etoricoxib and Acetaminophen in Tablet Dosage Form

Wael Abu Dayyih, Maha Al Mufty, Mohammad Hailat, Riad Awad, Mohammad Riad Awad, Mohammed F. Hamad

Abstract

This study aimed to create a tablet with etoricoxib and acetaminophen to improve patient compliance. A selective, simple, precise, and economical HPLC method was developed and validated for quantifying acetaminophen and etoricoxib in tablet form. The drugs were separated using a mobile phase consisting of methanol, acetonitrile, and phosphate buffer at pH 3.4, flowing through an ODS C18 column at a rate of 1.0 ml/min at 25°C. At concentrations of 10-180 µg/ml for acetaminophen and 1-50 µg/ml for etoricoxib, linearity was established with a regression coefficient of 0.9992. No interaction or degradation was found for the combination product. ICH-compliant results with a 2% RSD were satisfactory. This method is robust to pH, temperature, detector wavelength, column, and mobile phase composition changes. This method is ideal for routine analysis of acetaminophen and etoricoxib tablets because of its simplicity and low reagent cost. The HPLC method for estimating acetaminophen and etoricoxib in combined dosage forms was sensitive, accurate, precise, linear, stable, and robust. Acetaminophen and etoricoxib in pharmaceutical formulations can be tested using the proposed method for quality control and routine analysis. Our combination formulation method yielded a non-friable tablet with good performance, hardness, and disintegration. We recommend this HPLC method for the routine analysis of raw materials and formulations.

 

Keywords: acetaminophen, etoricoxib, HPLC, validation, ICH guidelines.

 

https://doi.org/10.55463/issn.1674-2974.51.5.1


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