STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR, VELPATASVIR, AND VOXILAPREVIR IN BULK AND TABLET DOSAGE FORMS
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.
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