Evaluation of Naproxen and Esomeprazole in Bulk and Pharmaceutical Tablets Dosage Form by RP-Chromatography

Abstract

An original, trustworthy, simple, precise, rapid, sensitive, and accurate RP-HPLC method was validated for quantifying naproxen and esomeprazole in both conventional and synthetic mixed formulation tablets. The maximum absorbances of Naproxen and Esomeprazole in a 60:40 (vol/vol) mixture of deionized water and methanol were 244.8 and 272.6nm, respectively. To isolate naproxen from esomeprazole, a Shimadzu LC-20-A RP-HPLC is employed equipped with a C18 Phenomenex column (250mm 4.6mm 5 µm). Elution was done with a methanol-water eluent (40:60 V/V). Both naproxen and esomeprazole were eluted within (3.468 and 5.376 min, respectively) after a 10-minute separation at 270 nm using a UV-Vis detector and a flow rate of 1.0 mL/min. Elution-phase conditions were studied, including elution-phase composition, flow rate, pH, and wavelength. Naproxen and esomeprazole both had linearity ranges of 0.5 -25 µg/mL and 0.1 -30 µg/mL, respectively, with R2 values of 0.9995 and 0.9997, and means of recovery of 99.57 and 100.36, respectively. The method was used to samples of medications in different dosage forms in order to determine their gradient active. The average recovery % was used to determine whether the technique was accurate, and it was determined to be within a reasonable range.