Friday , 19 July 2024

Method Development and Validation for Simultaneous Estimation of Velpatasvir and Sofosbuvir by Using RP-HPLC in Bulk and Pharmaceutical Dosage Form

Durbhakula Pradhathri*, P. Sirisha, AVSS. Gupta, A. Mohan Goud, P. Nagaraju, M. Shyamala, J. V. C. Sharma, G. Srimounika, B. Anusha Reddy, V. Revathi
Department of Pharmaceutical Analysis & Quality Assurance, Joginpally BR Pharmacy College, Moinabad, Rangareddy, Hyderabad, Telangana.

A New method was established for simultaneous estimation of Velpatasvir And Sofosbuvir by RP-HPLC method.   Chromatographic separations were carried using YMC (4.6 x 150 mm, 5μm) column with a mobile phase composition of Phosphate buffer pH 3 and Acetonitrile(50:50) have been delivered at a flow rate of 1ml/min and the detection was carried out using waters HPLC auto sampler, separation module 2695 with dual λ absorbance detector 2487 at wavelength 255 nm. The retention time for Velpatasvir and Sofosbuvir were 3.472 and 5.505 minute respectively. The correlation coefficient values in linearity were found to be 0.999 and concentration range 50-250 μg/ml for Velpatasvir and 200-1000 µg/ml for Sofosbuvir respectively. For accuracy the total recovery was found to be 100.08% and 100.02% for Velpatasvir and Sofosbuvir. The LOD and LOQ for Velpatasvir was found to be 3.00 and 9.98 and LOD and LOQ for Sofosbuvir was found to be 2.98 and 10.00. The force degradation studies were performed and the results are within the limits. The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Velpatasvir and Sofosbuvir in pharmaceutical dosage form.

Keywords: Velpatasvir, Sofosbuvir, RP‐HPLC, Simultaneous estimation.

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