Stability Indicating HPTLC Method for Sofosbuvir and Daclatasvir in Combination
DOI:
https://doi.org/10.37285/ijpsn.2020.13.6.8Abstract
Direct acting antiviral agents represent the major advance in treatment of hepatitis C virus (HCV) infection. Daclatasvir with sofosbuvir that are co-administrated once per day oral dose has been reported to achieve a high rate of virological response in patients with HCV genotype 1, 2 or 3. So, the basic objective of a research involved development and validation of stability indicating HPTLC Method for simultaneous estimation of Sofosbuvir and Daclatasvir available in market in the form of combination tablet. Samples were applied on HPTLC aluminium plates precoated with silica gel 60 F254 (250μm thickness). Mobile phase consists of ethyl acetate: isopropanol in the ratio 9:1v/v. A good resolution was observed between peaks of both the drugs. The retention factor for Sofosbuvir is about 0.51 ±0.02. And for Daclatasvir is about 0.30 ± 0.02. Deuterium lamp as a source of radiation at the wavelength of 260 and 318 nm for analysis of Sofosbuvir and Daclatasvir, respectively. The proposed method was validated according to ICH guidelines and the results were acceptable for linearity and range, accuracy, precision, robustness, detection limit and quantitation limit. The calibration curves were linear over a wide range of 200-1000 ng/band (r2= 0.991) for Sofosbuvir and 45-225 ng/band (r2=0.990) for Daclatasvir. The limit of detection was found to be 21.17 ng/band and 4.38 ng/band for SOF and DAC and limit of quantitation was 64.18 ng/band and 13.28 ng/band for SOF and DAC respectively. During stress degradation study, it was observed that the Daclatasvir is degraded less in thermal and photolytic condition but more in basic hydrolysis condition. Sofosbuvir was found to be sensitive to all stress conditions except the fluorescent light. The suggested method was successfully applied for analysis of both drugs and excellent recovery results were obtained. Being simple, fast, robust, and economic, the method could be applied to the quality control and routine stability monitoring of Sofosbuvir and Daclatasvir.
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Keywords:
Daclatasvir, Sofosbuvir, HPTLC, Stability indicating method, Validation, ICH
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