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2019 Volume 10 Issue 1

Quantitative Determination of Entecavir in Bulk and Tablet Formulation by a Validated Stability-indicating Reversed-phase HPLC Method


Gunasekar Manoharan, Ramadan Abdel Wahed Mohamed
Abstract

A simple and gradient RP- HPLC method has been validated and developed for Entecavir in bulk and tablet dosage form. The proposed method was validated to obtain official requirements including stability, accuracy, precision, linearity and selectivity. The method was developed on C18 column (250 x 4.6 mm ID) using the mobile phase composition as methanol: water (55:45 v/v). The flow rate was set as 1ml/minute and the maximum absorption was observed at 254 nm. The Entecavir drug showed a precise and good linearity at the concentration ranges of 5-25 µg/ml. The RP-HPLC, assay showed the highest purity ranging from 98.79 % to 99.91 % for Entecavir tablet formulation and 99.22 % was the mean percentage purity. The Entecavir retention time was found to be 3.5 minutes. The method accuracy was showed by statistical analysis. The developed RP-HPLC method can be utilized for the regular analysis of Entecavir in bulk and pharmaceutical dosage types in quality control laboratories. The proposed method was validated based on the ICH guidelines.


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JOURNAL OF BIOCHEMICAL TECHNOLOGY
JOURNAL OF BIOCHEMICAL TECHNOLOGY
Journal of Biochemical Technology is a peer reviewed International Journal published by the Sevas Publishing on behalf of the Biochemical Technology Society, a Registered Charity Organization from India

AREA OF INTEREST
AREA OF INTEREST
Areas of high interest, cover new advances in enzymatic and protein mechanims; applied molecular genetics and biotechnology; genomics and proteomics; metabolic; medical, environmental, food and agro biotechnology.

FOCUS AND SCOPE
FOCUS AND SCOPE
Journal Of Biochemical Technology” Provides A Medium For The Rapid Publication Of Full-Length Articles, Mini-Reviews Of New And Emerging Products And Short Communications On All Aspects Of ...

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This journal provides immediate open access to its content on the principle that making research freely available to the public supports a greater global exchange of knowledge. Keywords include, Biochemical Research: Endo/exocytosis, Trafficking, Membrane Biology, Cell Migration, Cell-Matrix Organelle Biogenesis, Cytoskeleton Proteolysis, Cell Death, Cell Cycle, Cancer, Cell Growth/Death, Differentiation, Drug Targets, Gene Therapy, Models of Disease, Proteomics, Stem Cells, Bioenergetics, Mitochondria, Free Radicals, Redox Signaling, Ion Transport/Channels, Oxidative