Development and validation of a high-performance liquid chromatography method for the estimation of esomeprazole in bulk and tablet dosage form

Abstract

Introduction: An accurate, simple, precise, rapid, economic and reproducible reverse-phase high-performance liquid chromatography method was developed and validated for the estimation of Esomeprazole (ESO) in bulk and tablet dosage form. Method: The separation was carried out on Finepak SIL C18T-5 column (250 × 4.6 mm, 5.0 µm i. d.) using potassium dihydrogen phosphate buffer (0.025M): ACN (20:80 v/v) and at a flow rate of 1.0 mL/min. using UV detector at 302 nm with a run time of 10 min. The method was validated for accuracy for linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) and robustness. Results: The standard calibration curve was linear with R2 = 0.995. LOD and LOQ obtained for esomeprazole were 0.0001 and 0.0004 µg/mL respectively. The method was found robust for possible changes. Results of analysis of other parameters were also tested and validated as per ICH guidelines and recovery studies confirmed the accuracy of the proposed method. validation studies showed that the developed HPLC method is simple, reproducible, rapid, precise and reliable. The high recovery and low relative standard deviation confirm the suitability of the developed method for the determination of esomeprazole in the tablet dosage form. Conclusion: This method may be used as a more convenient and efficient option for the analysis of esomeprazole to establish the quality of the substance during routine analysis with consistent and reproducible results.