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 stainless steel Purospher® STAR Hibar® C18 analytical column (250 mm × 4.6 mm i.d., 5.0 μm) using acetonitrile and phosphate buffer (0.05 M) in the ratio 50:50 v/v as mobile phase and at a flow rate of 1.2 ml/min. Detection was carried out using a UV detector at 301 nm. The method was validated for accuracy, precision, linearity, LOD, LOQ and robustness. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 3-21 μg/ml with R2 close to one (0.999). The limit of detection (LOD) and limit of Quantitation (LOQ) obtained for esomeprazole were 0.000065 μg/ml and 0.000197 μg/ml, respectively. The developed and validated method was successfully applied for the quantitative analysis of Nexpro® tablets. This method can be used as more convenient and efficient option for the analysis of esomeprazole to establish the quality of the drug substance during routine analysis with consistent and reproducible results.
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