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A Bioanalytical Method Development and Validation for Simultaneous Determination of Velpatasvir and Sofosbuvir in Spiked Human Plasma
Corresponding Author(s) : R.S. Ch. Phani
Asian Journal of Chemistry,
Vol. 29 No. 11 (2017): Vol 29 Issue 11
Abstract
A simple, precise, accurate and sensitive, isocratic RP-HPLC method has been developed and validated for the estimation of velpatasvir and sofosbuvir in plasma. Method was developed with, Intersil ODS C18 column (250 mm × 4.6 mm × 5 μ), mobile phase mixture of acetonitrile and water having pH of 6.5 in the ratio of (80:20 v/v) at flow rate 1 mL/min. at UV detector wavelength of 240 nm. Mobile phase pH was adjusted with 1 % o-phthalaldehyde (OPA). The retention times are 3.49 min for sofosbuvir and 6.15 min for velpatasvir, Quantitative linearity was obeyed in the concentration range of 0.1 to 0.8 μg/mL for sofosbuvir and 0.025 to 0.2 μg/mL for velpatasvir. The limit of detections are 0.006 μg/mL for sofosbuvir, 0.0017 μg/mL for velpatasvir and limit of quantifications are 0.0125 μg/mL for sofosbuvir, 0.003 μg/mL for velpatasvir for which indicates the sensitivity of the method. The average recovery of sofosbuvir is 100.75 and 99.25 % for velpatasvir. The high percentage recovery indicates that the proposed method is highly accurate. Bench top, Auto sampler, Freeze and Thaw stability test are performed.
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References
L.S. Goodman and A.G. Gilman, eds.: J.G. Hardman and L.E. Limbard, The Pharmacological Basis of Therapeutics, McGraw Hill, edn 9 (1996).
J.J. Feld, I.M. Jacobson, C. Hézode, T. Asselah, P.J. Ruane, N. Gruener, A. Abergel, A. Mangia, C.-L. Lai, H.L.Y. Chan, F. Mazzotta, C. Moreno, E. Yoshida, S.D. Shafran, W.J. Towner, T.T. Tran, J. McNally, A. Osinusi, E. Svarovskaia, Y. Zhu, D.M. Brainard, J.G. McHutchison, K. Agarwal and S. Zeuzem, N. Engl. J. Med., 373, 2599 (2015); https://doi.org/10.1056/NEJMoa1512610.
B. Raj Kumar and K.V. Subrahmanyam, Indo-Am. J. Pharm. Res., 6, 450 (2016).
B. Zaman, F. Siddique and W. Hassan, Chromatographia, 79, 1605 (2016); https://doi.org/10.1007/s10337-016-3179-9.
M. Vikas, T. Satyanarayana, D. Vinod Kumar, E. Mounika, M. Sri Latha, R. Anusha and Y. Sathish, World J. Pharm. Pharm. Sci., 5, 775 (2016).
M. El-Kassem M. Hassouna, M.M. Abdelrahman and M.A. Mohamed, J. Forensic Sci. Crim. Invest., 1, 555562 (2017); https://doi.org/10.19080/JFSCI.2017.01.555562.
R. Vejendla, C.V.S. Subramanyam and G. Veerabhadram, Indo-Am. J. Pharm. Res., 5, 2098 (2015).
V.A. Chakravarthy, B.B.V. Sailaja and A.P. Kumar, Asian J. Pharm. Clin. Res., 9, 61 (2016); https://doi.org/10.22159/ajpcr.2016.v9s2.13687.
B. Prasanthi, J.V. Ratna and R.S.C. Phani, J. Anal. Chem., 70, 1015 (2015); https://doi.org/10.1134/S1061934815080146.