DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR THE ESTIMATION OF SOFOSBUVIRAbstract
A simple stability-indicating high-performance thin-layer chromatographic method which is economic, selective, and precise for analysis of Sofosbuvir (SFB), both as a bulk drug and in formulations, was developed and validated according to ICH guidelines. The method employed HPTLC precoated Merck TLC plates RP-18 F254 as the stationary phase while the solvent system prepared by mixing n-Hexane: Ethyl Acetate: Methanol in proportion 5:3:2 v/v. The system was found to give a compact spot for the drug (Rf value of 0.452 ± 0.004). Densitometric analysis of SFB was carried out in the absorbance mode at 261 nm. The linear regression analysis data for the calibration plots showed a good linear relationship, R2 = 0.9994, with respect to peak area in the concentration range 100-600 ng/band. The LOD and LOQ were 8.009 ng/band and 24.270 ng/band, respectively. SFB was subjected to hydrolysis, oxidation, and thermal degradation, which indicates the drug is susceptible to hydrolysis, oxidation, and heat. The method was validated for precision, recovery, and robustness. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of SFB.
M. R. Ghante *, S. D. Sawant, A. Shinde and V. K. Bhusari
Sinhgad Technical Education Society’s, Smt. Kashibai Navale College of Pharmacy (Kondhwa), Pune, Maharashtra, India.
26 April 2020
10 December 2020
18 December 2020
01 May 2021