Abstract
Objective: The present study was aimed to develop a novel, simple, rapid accurate and precise, stability-indicating reversed-phase high-performance liquid chromatography method for the simultaneous estimation of sofosbuvir, velpatasvir, and voxilaprevir in bulk and tablet dosage forms.
 Methods: The chromatographic elution was achieved in isocratic mode using the combination of sofosbuvir, velpatasvir, and voxilaprevir in the ratio of acetonitrile and water (65:35%v/v) using a Phenomenex C18 column which has specification (150 × 4.6 mm, 5 μ particle size) and the flow rate of 1.0 ml/min and wavelength (ultraviolet) detection at 220 nm.
 Results: The retention time obtained for sofosbuvir, velpatasvir, and voxilaprevir was 2.213 min, 2.568 min, and 2.917 min, respectively. Sofosbuvir, velpatasvir, and voxilaprevir and their combination drug product were exposed to acidic, alkali, thermal, photolytic, and oxidative stress conditions. The current method was validated according to the ICH guidelines for accuracy, precision, linearity, specificity, and sensitivity.
 Conclusion: The method developed is more sensitive, accurate, precise, and robust then the methods reported earlier. Retention time and run time were decreased; hence, the method is economical simple and precise. Forced degradation studies indicated for the suitability of the method for stability studies of sofosbuvir, velpatasvir, and voxilaprevir. The proposed method can be used for routine quality control analysis test in pharmaceutical industries.
Highlights
Hepatitis C virus (HCV) was found to be a commonly attacking disease to human beings and was increased day by day
Materials and methods The reference samples of sofosbuvir, velpatasvir, and voxilaprevir were provided as a gift sample from spectrum Pharma Research Solutions, Hyderabad
VOSEVI tablets labeled to contain sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg were purchased from the local pharmacy store
Summary
Hepatitis C virus (HCV) was found to be a commonly attacking disease to human beings and was increased day by day. The literature reveals that 72% of the patients were suffered from chronic HCV [1]. 75–85% of the liver is persisted with the virus. These defects have been treated by the use of oral form of these combinational drugs, respectively [2]. Sofosbuvir is an antiviral drug in the treatment of chronic HCV [3,4].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: Asian Journal of Pharmaceutical and Clinical Research
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
