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Bioanalytical method validation of Esomeprazole by high performance liquid chromatography with PDA detection

Moni Fatema, Sharmin Suriya, Rony Satyajit Roy, Afroz Farhana, Akhter Shammi, Sohrab Md. Hossain

Acta Chromatographica

2021

Vol. 33, no. 2

120--126

This study describes the development and validation of a simple, specific, accurate, and precise method for quantitative determination of Esomeprazole in human serum using Pantoprazole as internal standard (IS). After the addition of internal standard, Esomeprazole from serum samples was extracted simply by protein precipitation method followed by centrifugation and the supernatants were directly injected into the high performance liquid chromatography (HPLC). The chromatographic separation of the compounds was obtained on Hitachi Lachrom C8 column (5 µm, 250 × 4.6 mm) with a mobile phase consisting of 5 mM potassium dihydrogen phosphate pH 7.4 and acetonitrile in a ratio of 70:30 with UV detection at 302 nm with a flow rate of 1 mL/min. The method was sensitive and specific, and validated over a concentration range of 0.06–6.0 µg/mL. The limit of detection (LOD) and lower limit of quantification (LOQ) was 0.03 µg/mL and 0.06 µg/mL, respectively. The precision and accuracy expressed as relative standard deviation were less than 15%. The average recovery of Esomeprazole from serum was 97.08%.