Development and Validation of RP-HPLC Method for Simultaneous Estimation of Aspirin and Esomeprazole Magnesium in Tablet Dosage Form

Abstract EN

A simple, specific, precise, and accurate reversed-phase HPLC method was developed and validated for simultaneous estimation of aspirin and esomeprazole magnesium in tablet dosage forms.

The separation was achieved by HyperChrom ODS-BP C18 column (200 mm × 4.6 mm; 5.0 μm) using acetonitrile: methanol: 0.05 M phosphate buffer at pH 3 adjusted with orthophosphoric acid (25 : 25 : 50, v/v) as eluent, at a flow rate of 1 mL/min.

Detection was carried out at wavelength 230 nm.

The retention times of aspirin and esomeprazole magnesium were 4.29 min and 6.09 min, respectively.

The linearity was established over the concentration ranges of 10–70 μg/mL and 10–30 μg/mL with correlation coefficients (r2) 0.9986 and 0.9973 for aspirin and esomeprazole magnesium, respectively.

The mean recoveries were found to be in the ranges of 99.80–100.57% and 99.70–100.83% for aspirin and esomeprazole magnesium, respectively.

The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of aspirin and esomeprazole magnesium in their combined tablet dosage form.