Analytical method development and validation of related substances by rphplc of sofosbuvir and velpatasvir tablets

Jay Bhatt, Ujashkumar A. Shah,  Hirakkumar V. Joshi

Department of Quality Assurance and Pharmaceutical chemistry, Sakalchand Patel University, Visnagarn, Gujarat, In

Refer this article

Jay Bhatt, Dr. Ujashkumar A. Shah, Dr. Hirakkumar V. Joshi,
2022. Analytical method development and validation of related
substances by RP-HPLC of sofosbuvir and velpatasvir tablets.
Journal of Medical Pharmaceutical and allied Science V 11 - I
4, Pages - 5201 – 5213. Doi: 10.55522/jmpas.V11I4.4051.

ABSTRACT

The developed method was a simple, accurate, precise, specific and robust method for the validation of Sofosbuvir and Velpatasvir Tablets by reverse phase high pressure liquid chromatography. For Sofosbuvir and Velpatasvir Tablets Chromatography was performed on Agilent 1200 series, UV and PDA Detector, Waters X-bridge C18 (150 mm x 4.6 mm, 3.5 μm) by using Mobile Phase A contains Buffer solution (0.6% Trifluroacetic acid in water adjusted pH to 2.2±0.05) : Acetonitrile (95:5)%v/v and Mobile Phase B contains mixture of purified water, methanol and acetonitrile in the ratio of (20: 30: 50) % v/v/v. at a flow rate of 1.0 mL/min and at 263 nm for Sofosbuvir and 320 nm for Velpatasvir wavelength. The retention times of About 48.0 minutes for Sofosbuvir and About 78.8 minutes for Velpatasvir respectively. Methyl Uridine and Impurity at RRT 0.39 found linear over the range of LOQ - 150 % of target concentration. Method also found precise by spiking impurities at specification level. Accuracy was demonstrate at LOQ - 150 % level by preparing sample in triplicate for each level and found accurate. Hence, the method could be successfully used for the analysis Impurities in Sofosbuvir and Velpatasvir Tablets Tablet.

Keywords:

Sofosbuvir, Velpatasvir, HPLC, UV and PDA Detector, Dual Wavelength, Related Substances

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