A NEW VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ESOMEPRAZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORMAbstract
Reverse Phase High-Performance Liquid chromatography is a widely and commonly used analytical method for qualitative and quantitative analysis. A simple, accurate, economical, rapid, and precise RP-HPLC process has been proposed and validated for the determination of esomeprazole in immense bulk and dispensed pharmaceutical drug form. The RP-HPLC separation was achieved on Symmetry ODS RP C18, 5 µm, 15 mm × 4.6 mm i.d. column using mobile phase Phosphate buffer (pH=3.6): ACN = 50:50 pH Adjudged with Orthophosphoric acid at continuance effusion of 1.0 ml/min at ambient temperature. The retention times were observed at 3.797 min for esomeprazole. The calibration plot is linear beyond the concentration range 0-50 μg/ml for esomeprazole. Quantification was achieved with UV detection at 246 nm over the Beer-Lambert’s range. The proposed methodology is validated statistically as per the ICH guidelines for various validation parameters includes, including Accuracy, Precision, Linearity and range, Limit of detection, and Limit of Quantification. The above method is developed and validated successfully for the routine quantitative analysis of esomeprazole in bulk and pharmaceutical dosage form.
Nellore Dharani Sai Sreekanth, Nenavath Adilakshmi, Doddi Anusha, Gurram Sowmya and Pogaku Surya Teja
Department of Pharmaceutical Analysis, Ibrahimpatnam, Telangana, India.
19 September 2020
22 June 2021
06 July 2021
01 September 2021