Volume : 13, Issue : 08, August – 2026
Title:
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS QUANTIFICATION OF VOXILAPREVIR, VELPATSAVIR AND SOFOSBUVIR IN ACTIVE PHARMACEUTICAL INGREDIENT AND COMBINED PHARMACEUTICAL DOSAGE FORMS
Authors :
Thatikyla Mahender*, Yede Siddhartha
Abstract :
A simple, rapid, accurate, and stability-indicating reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Voxilaprevir, Velpatasvir, and Sofosbuvir in active pharmaceutical ingredients and combined pharmaceutical dosage forms. The method development was performed by optimizing various chromatographic parameters, including stationary phase, mobile phase composition, flow rate, detection wavelength, and injection volume. Chromatographic separation was achieved using an X-Bridge C18 column (250 × 4.6 mm, 5 µm) with an optimized mobile phase consisting of [mobile phase composition to be inserted] at a flow rate of [flow rate] mL/min. The analytes were detected at 260 nm using a photodiode array detector. The developed method demonstrated excellent linearity over the selected concentration ranges with correlation coefficients (r²) greater than 0.999 for all three drugs. The method exhibited satisfactory accuracy with percentage recovery within acceptable limits, while precision studies showed low %RSD values confirming the reproducibility of the method. Specificity studies confirmed the absence of interference from formulation excipients. Forced degradation studies under acidic, alkaline, oxidative, thermal, photolytic, and neutral conditions demonstrated effective separation of degradation products from the analyte peaks, confirming the stability-indicating capability of the method. The validated RP-HPLC method was successfully applied for the simultaneous quantification of Voxilaprevir, Velpatasvir, and Sofosbuvir in marketed pharmaceutical dosage forms. The developed method is simple, robust, economical, and suitable for routine quality control and stability analysis.
Keywords: Voxilaprevir; Velpatasvir; Sofosbuvir; RP-HPLC; Stability-indicating method; Forced degradation; Method validation; ICH guidelines.
Cite This Article:
Please cite this article in press T Mahender et al., Development and Validation of Stability indicating RP-HPLC method for the simultaneous quantification of Voxilaprevir, Velpatsavir and Sofosbuvir in active Pharmaceutical ingredient and combined Pharmaceutical dosage forms.,, Indo Am. J. P. Sci, 2026; 13(08).
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