DEVELOPMENT AND VALIDATION OF A NOVEL STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF ENTECAVIR IN TABLET FORMULATION
N. Naidu*, Gundala Sudheer Kumar, B. Suresh, Maddali Kalpana and Andrra Sreelatha
A precise and selective RP-HPLC method has been developed for the estimation of entecavir in tablet dosage form. A Agilent HC-C18 (250 x 4.6 mm i.d., particle size 5 μm) column with, Buffer: Acetonitrile in the ratio of (95:5) was employed as mobile phase. The flow rate of 1 mL/min was used and the effluents were detected at 253 nm. The retention time was found to be 6.98 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 2.05-15.53 μg/mL, accurate (recovery of about 99.9% with % RSD of <2), highly precise (% RSD of <2 in both intra-day and inter-day study), and robust enough to deliver accurate resultshus, this simple method will help in determination of entecavir prove beneficial in quality control of drug.
Keywords: entecavir, RP-HPLC, estimation, validation, forced degradation.
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