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Development and Validation of a Novel Stability Indicating RP-HPLC Method for the Estimation of Entecavir in Tablet Formulation


Sachin T. Deodhe, Disha M. Dhabarde, Manish A. Kamble, Debarshi Kar Mahapatra

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Keywords

Entecavir, RP-HPLC, estimation, validation, forced degradation

Abstract

A precise and selective RP-HPLC method has been developed for the estimation of entecavir in tablet dosage form. A Phenomenox C18 (250 x 4.6 mm i.d., particle size 5 μm) column with, water (pH 3.0 adjusted by glacial acetic acid) and acetonitrile (95:5) was employed as mobile phase. The flow rate of 1 mL/min was used and the effluents were detected at 254 nm. The retention time was found to be 7.724 min. The method was further validated for linearity, accuracy, precision, and robustness where the method was found to be linear over the range concentration range of 5-30 μg/mL, accurate (recovery of about 99.2% with % RSD of <2), highly precise (% RSD of <2 in both intra-day and inter-day study), and robust enough to deliver accurate results. Forced degradation studies of entecavir were performed under neutral, acidic, alkaline conditions along with photolysis and oxidative conditions, where the drug exhibited degradation and various peaks were monitored. Highest degradation was observed under basic condition. Thus, this simple method will help in determination of entecavir and the result of degradation studies will help in both qualitative and quantitative determination of degraded products and may prove beneficial in quality control of drug.