Simultaneous determination of aspirin and esomeprazole magnesium in combined tablets by validated UPLC method

Abstract

Aim and backgroundA stability-indicating ultra performance liquid chromatography (UPLC) method has been developed and validated for the simultaneous determination of aspirin and esomeprazole magnesium in pharmaceutical preparations. Materials and methodsAn Agilent Zorbax XDB column (50 × 4.6 mm i.d., 1.8 μm particle size) was used. The mobile phase consisted of a mixture of 0.2% orthophosphoric acid, methanol, and acetonitrile in simple gradient elution. Ultraviolet (UV) detection was performed at 210 nm. Total run time was 6 min; the two drugs were eluted at the retention times of 2.4 and 2.8 min for esomeprazole and aspirin, respectively. ResultsThe linearity for both the drugs was found in the range of 32–98 μg/ml for aspirin and 4–12 μg/ml for esomeprazole magnesium. The percentage recoveries of aspirin and esomeprazole magnesium were found to be 99.1–100.5 and 99.2–100.1, respectively. The method distinctly separated the drug and degradation products even in actual samples. ConclusionThe method was validated in terms of linearity, range, specificity, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ).