STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR, VELPATASVIR, AND VOXILAPREVIR IN BULK AND TABLET DOSAGE FORMS
Keywords:Sofosbuvir, Velpatasvir, and voxilaprevir, Reversed-phase high-performance liquid chromatography, Stability indicating, Validation
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.
Rani JS, Devanna N. Development and validation of RP-HPLC method for the simultaneous estimation of sofosbuvir, velpatasvir and voxilaprevir in bulk and tablet dosage forms. Rasayan J Chem 2018;11:452-9.
Balaswami B, Ramana PV, Rao BS, Sanjeeva P. A new simple stability indicating RP-HPLC-PDA method for simultaneous estimation of triplicate mixture of sofosbuvir, voxilaprevir and velpatasvir in tablet dosage form. Res J Pharm Technol 2018;11:4147-56.
Sofosbuvir, Drug. Available from: https://www.drugbank.ca/drugs/ db08934.
Velpatasvir, Drug. Available from: https://www.drugbank.ca/drugs/ db11613.
Voxilaprevir, Drug. Available from: https://www.drugbank.ca/drugs/ db12026.
Lalitha KV, Reddy JR, Devanna N. Stability indicating RP-HPLC method development and validation for estimation of sofosbuvir in pharmaceutical dosage forms. Pharma Innov 2018;7:656-62.
Sathar MD, Suneetha A. RP-HPLC method development and validation for velpatasvir and voxilaprevir by simultaneous determination in bulk and their pharmaceutical dosage forms. Int J Chem Pharm Sci 2018;6:36-42.
Devi LM, Reddy TR, Abbul K. Simultaneous determination and validation of third generation antiviral drugs by RP-HPLC method. Int J Pharm Anal Res 2019;8:1-8.
Rani JS, Devanna N. A new RP-HPLC method development and validation for simultaneous estimation of sofosbuvir and velpatasvir in pharmaceutical dosage forms. Int J Eng Technol Sci Res 2017;4:145-52.
Nalla S, Rao JV. A stability indicating RP-HPLC method for simultaneous estimation of velpatasvir and sofosbuvir in combined tablet dosage forms. World J Pharm Pharm Sci 2017;6:1596-611.
ICH Guidelines Q2 (R1), Validation of Analytical procedures, Text and Methodology; 1995.
ICH Guidelines Q1A (R2), Stability Testing of New Drug Substances and Products, International Conference on Harmonization; 2003.
Madhavi S, Ravi AP. Method development and validation for the determination of sofosbuvir from human plasma. Int J Pharm Pharm Sci 2017;9:1.
Vanitha C, Reddy B, Satyanarayana SV. Quality-by-design approach to selective stability indicating RP-HPLC method development and validation of estimation of sofosbuvir in bulk drug. Int J Res Pharm Sci 2018;9:298-308.
How to Cite
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.