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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
ISSN
0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF HEPATITIS C VIRUS NS5B INHIBITOR DRUGS SOFOSBUVIR AND LEDIPASVIR IN THEIR DOSAGE FORMS

Author: SIVA , CHINTALA RAMBABU
Abstract: A simple, accurate, isocratic stability indicating RP–HPLC method for the determination of sofosbuvir and ledipasvir in pure and in pharmaceutical formulations. Method was developed using methanol and acetate buffer in 78:22 (v/v) ratio as mobile phase at pH 4.9 using Agilent ZORBAX Eclipse Plus C18 (250 mm x 4.6 mm, 5µm) column as stationary phase. The flow rate and detection wavelength were 1.0 mL/min and 228 nm respectively. The linearity range of the method was found to be 4.5-27 µg/mL for ledipasvir and 20-120 µg/mL for sofosbuvir. The developed method was validated as per ICH guidelines and the results of all the validation parameters were well within acceptable limits. The degradation products formed during different stress conditions in stability studies were separated from both drugs and also from individual degradation products. The results obtained in this research work clearly indicated that the developed method is simple, selective, precise, accurate, robust and rugged. Hence, this validated method can be applied for the simultaneous estimation of sofosbuvir and ledipasvir in commercially available formulation sample.
Keyword: sofosbuvir, ledipasvir, HPLC, method development, Validation, Forced degradation
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