STABILITY INDICATING HPTLC METHOD FOR SOFOSBUVIR AND VELPATASVIR IN COMBINATION
Abstract
The discovery of new direct-acting antiviral drugs gave rise to a leap forward in the treatment of hepatitis C viral infections. For the first time since 1998, the Food and Drug Administration (FDA) approved interferon-free oral treatment paradigms. Among the new treatment regimens, the combinations of Sofosbuvir and Velpatasvir became ideal treatment regimens for being potent, highly tolerated and used once daily. Hence an accurate, precise, selective and sensitive stability indicating method for simultaneous estimation of Sofosbuvir and Velpatasvir by High-Performance Thin Layer Chromatography has been developed and validated. Chromatographic separation was achieved on TLC plates coated with silica gel 60 F254 as stationary phase. Ethyl acetate: iso-propyl alcohol (9:1 v/v) was used as mobile phase.Densitometric scanning was carried out at 260 and 302 nm for Sofosbuvir and Velpatasvir, respectively. The method was successfully validated as per the ICH Guideline. The linear concentration range was100- 2000 ng/band (r2= 0.991) and 100-500 ng/band (r2 = 0.991) for SOF (Sofosbuvir) and VEL (Velpatasvir) respectively. The LOD were 25.16 ng/band and 9.96 ng/band for SOF and VEL, LOQ were 76.25 ng/band and 30.19 ng/band for SOF and VEL.The method could be applied to the quality control and routine analysis of Sofosbuvir and Velpatasvir in their pure forms and pharmaceutical formulations.
Keywords:
Sofosbuvir, Velpatasvir, High performance thin layer chromatography, stability indicating method, Hepatitis-C.DOI
https://doi.org/10.25004/IJPSDR.2020.120206References
Elkady EF, Aboelwafa AA. Rapid bioanalytical LC-MS/MS method for the simultaneous determination of SOR and VEL in human plasmaapplication to a pharmacokinetic study in Egyptian volunteers. Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. 2018;1(1102-1103):116-124.
Rani JS, Devanna N. A New RP-HPLC Method Development and Validation for Simultaneous Estimation of SOR and VEL in Pharmaceutical Dosage Form. International Journal of Engineering Technology Science and Research. 2017;4(11):145-152.
Rao PV, Rao AL, Prasad SVUM. Validated Stability Indicating RP-HPLC method for estimation of antiviral class of drugs SOR and VEL in combination and its comparison with reported methods. Research Journal of Pharmacy and Technology. 2018;11(12):5425-5430.
Saroja J, Anantha Lakshmi PV, Rammohan Y, Divya D, Santhosh Kumar P. Concurrent estimation of SOR and VEL in raw and tablets using stability indicating RP-HPLC method. Rasayan Journal of Chemistry. 2018;11(3):1058-1066.
Rao LA, Pallavi A. Method Development and Validation of Stability Indicating RPHPLC Method for Simultaneous Estimation of SOR and VEL in Tablet Dosage Form. Pharmaceutical Sciences & Analytical Research Journal. 2019;2(1):180014.
Rezk MR, Basalious EB, Badr KA. Novel determination of SOR and VEL in human plasma by UPLC-MS/MS method. Application to a bioequivalence study. Biomedical chromatography. 2019;32(11):e4347.
Kamal AH, Mabrouk MM, Bebawy L, Mekky MA. Spectrophotometric and robust UPLC methods for simultaneous determination of VEL and SOR in their tablet. Microchemical Journal. 2019;149:103996.
Rezk MR, Monir HH, Marzouk HM. Novel determination of a new antiviral combination; SOR and VEL by high performance thin layer chromatographic method; application to real human samples. Microchemical Journal. 2019;146:828-834.
Saraya RE, Elhenawee M, Saleh H. Development of a High-Performance Thin-Layer Chromatographic Method for the Simultaneous Determination of Newly Co-formulated Antiviral Drugs SOR and VEL in Their Pure Forms and Tablet Dosage Form. Journal of Planar Chromatography. 2019;32(2):141–147.
ICH Q2 (R1), ‘Validation of analy tical procedures text and methodology’, International Conference on Harmonization, Geneva 2005; 1-13.
Published

