A simple, accurate, precise RP-HPLC method was developed for the simultaneous estimation of the Sofosbuvir, Velpatasvir and Voxilaprevir Tablet [Vosevi®] dosage form. The method was carried through Agilent C18 150 x 4.6mm, 5m, with mobile phase containing buffer 0.01N Na2HPO4 and acetonitrile in the ratio of 60:40, pumped through column at 1ml/min flow rate, pH was adjusted to 4.5 with dilute orthophosphoric acid solution at 220 nm wavelength. Retention time of Sofosbuvir, Velpatasvir and Voxilaprevir were 2.229 min, 2.957 min and 3.568 min respectively. The proposed triple combination method can be used for estimation of these drugs in combined dosage forms. All the validation study was found statistically significant because all the statistical parameters were within the acceptance range for both accuracy and precision. The %RSD of Sofosbuvir, Velpatasvir and Voxilaprevir were observed as 0.8, 1.0 and 0.7 respectively. The % recovery was obtained as 100. 27%, 100.78% and 100.10% for Sofosbuvir, Velpatasvir and Voxilaprevir respectively. The high recovery and low coefficient of variation % revealed the reliability of the method for quantitative study of three drugs in Vosevi® tablets. The method is a rapid and cost-effective quality-control tool for routine quantitative analysis of Sofosbuvir, Velpatasvir and Voxilaprevir in tablet dosage form.
Cite this article:
Tej Kumar Kokkirala, Duvvuri Suryakala. Stability indicating RP-HPLC Method development and Validation for the Estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in Bulk and Pharmaceutical dosage form. Research J. Pharm. and Tech. 2020; 13(11):5063-5071. doi: 10.5958/0974-360X.2020.00887.2
5. Sarath Nalla and Seshagiri Rao J.V.L.N. A stability indicating RP-HPLC method for simultaneous estimation of velpatasvir and sofosbuvir in combined tablet dosage forms. World journal of pharmacy and pharmaceutical sciences, 2017, 6 (9).
6. T. Nagaraju, S.V.M. Vardhan, D. Ravi Kumar and D. Ramachandran. A new RP-HPLC method for the simultaneous assay of sofosbuvir and ledipasvir in combined dosage form. International Journal of Chemtech research, 2017, 10(7), 761-768.
7. Md. Abdul sattar, A. Suneetha. RP-HPLC Method development and validation for velpatasvir and voxilaprevir by simultaneous determination in bulk and their pharmaceutical dosage forms. IJCPS, 2018, 6(1), 36–42.
8. Marakada Sridevi, T. Siva Rao and Challa Gangu Naidu, Development and validation of liquid chromatographic method for simultaneous determination of sofosbuvir, velpatasvir and voxilaprevir in fixed tablet dosage form. EJBPS, 2018, 5(5), 351-360.
9. Dongala T, Palakurthi AK. Stability‐indicating LC method for the simultaneous determination of methyl paraben, propyl paraben, butylated hydroxytoluene and alpha‐tocopherol contents in marijuana capsules. Journal of the Iranian Chemical Society. https://doi.org/10.1007/s13738-019-01799-9
10. VB Subramanian, NK Katari, T Dongala, SB Jonnalagadda. Stability‐indicating RP‐HPLC method development and validation for determination of nine impurities in apixaban tablet dosage forms. Robustness study by quality by design approach. Biomedical Chromatography ,2020. 34 (1), e4719. https://doi.org/10.1002/bmc.4719
11. Kumar, P.A.; raju, T.V.R.; thirupathi, D. Development and Validation of a Stability-Indicating LC-Method for the Simultaneous Estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurities. Sci. Pharm. 2013, 81, 139-150. https://doi.org/10.3797/scipharm.1210-18
12. Dongala T, Katari NK, Palakurthi AK, Jonnalagadda SB. Development and validation of a generic RP‐HPLC PDA method for the simultaneous separation and quantification of active ingredients in cold and cough medicines. Biomedical Chromatography. 2019; e4641. https://doi.org/10.1002/bmc.4641.
13. Dongala T, Katari NK, Palakurthi AK, Jonnalagadda SB. Stability-indicating HPLC method for simultaneous quantification of 14 impurities in excedrin tablet formulations and identification of new impurity by LC–MS in accelerated stability studies. Biomedical Chromatography. 2019; e4608. https://doi.org/10.1002/bmc.4608
14. Dongala T, Palakurthi AK, Velaveni KK, Katari NK, Development and Validation of RP-HPLC Method for Simultaneous Determination of Diclofenac Potassium and its Process Related Impurities in Solid Oral Dosage Form. J Chromatogr Sep Tech, 2018, 9: 412. doi: 10.4172/2157-7064.1000412.
15. T Dongala, LNR Katakam, AK Palakurthi, NK Katari. RP-HPLC Stability Indicating Method Development and Validation of Pseudoephedrine Sulfate and Related Organic Impurities in Tablet Dosage Forms, Robustness by QbD Approach. 2019. Analytical Chemistry Letters 9 (5), 697-710. https://doi.org/10.1080/22297928.2019.1696701.
16. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: validation of analytical procedures: text and methodology Q2 (R1). ICH. (2005).
17. AK Palakurthi, T Dongala. HPLC-UV Method Development for the Determination of EDTA in Oxycodone HCl Oral Liquids with Derivatization Technique. Robustness by Design of Experiments Approach.2019. Analytical Chemistry Letters 9 (5), 594-607.
18. LNR Katakam, Dongala T. A novel RP‐HPLC refractive index detector method development and validation for determination of trace‐level alcohols (un‐sulfated) in sodium lauryl sulfate raw material. Biomedical Chromatography.2020. https://doi.org/10.1002/bmc.4827.
19. Prasad Kancherla, Pallavi Alegete, Srinivas Keesari, Bhavyasri Khagga, Stability-Indicating RP-UPLC Method Development and Validation for the Process Related Impurities of Nebivolol and StructuralCharacterization of Its Forced Degradation Products by LC-MS/MS. British Journal of Pharmaceutical Research,14(6): 1-13, 2016: Article no.BJPR.31354.
20. LNR Katakam, Dongala T. Quality by design with design of experiments approach for the development of a stability‐indicating LC method for benzonatate and its impurities in liquid oral dosage form. Separation science plus. 2020 https://doi.org/10.1002/sscp.202000023
21. AK Palakurthi, T Dongala, RK Yalavarthi, J Anireddy, QbD based development of Extraction Procedure for simultaneous Quantification of Telmisartan, Amlodipine Besylate and Chlorthalidone in combination complex matrix formulation. Biomedical chromatography:2020. BMC, e4755.
22. Kumar P. A, Thirupathi D, Kumar Y. R, Jayashree A. Simultaneous Determination of Related Organic Impurities of Ibuprofen and Paracetamol in Combination Solid Dosage form by Rp-HPLC With Qbd Approach. Orient J Chem 2017;33(3). Available from: http://www.orientjchem.org/?p=33429