HPLC Method Development and Validation for the Estimation of Esomeprazole in Bulk and Pharmaceutical Dosage Form
A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of esomeprazole in bulk and tablet dosage forms. The separation was achieved on Thermo C18 analytical column (250 mm × 4.6 mm i.d., 5.0 μm) using acetonitrile and methanol in the ratio 50:50 v/v as mobile phase and at a flow rate of 1.0 ml/min. Detection was carried out using a UV detector at 300nm. The total chromatographic analysis time per sample was about 8.0min with esomeprazole eluting at retention time of about 6.863±0.3 min. The method was validated for accuracy, precision, specificity, linearity and sensitivity. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 5-25μg/ml with r2 close to one (0.999). The limit of detection (LOD) and limit of quantitation (LOQ) obtained for esomeprazole were 0.100μg/ml and 0.314μg/ml respectively. The developed and validated method was successfully applied for the quantitative analysis of ESOMZ 20 Tablet. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of esomeprazole in tablets dosage form.
Keywords: Analytical method development, Reversed phase HPLC method, ICH guidelines, Tablet dosage forms, Accuracy and precision
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