EXPLORATION OF HPTLC METHOD FOR ESTIMATION OF NUCLEOTIDE ANALOG INHIBITOR OF HEPATITIS C: SOFOSBUVIR

Sofosbuvir was a breakthrough new medication for the treatment of patients with chronic hepatitis C. Sofosbuvir has a number of ideal properties, including once daily dosing, no meal restrictions, few adverse effects, minimal drug-drug interactions, high genetic barrier to resistance, and relatively good safety and efficacy in patients with advanced liver disease. For that purpose, a simple, specific, precise High-Performance Thin-Layer Chromatographic (HPTLC) method for analysis of Sofosbuvir, both as a bulk drug and in tablets was developed and validated.  The method employed TLC aluminum plates pre-coated with silica gel 60 F₂₅₄ as the stationary phase. The solvent system consisted of dichloromethane: methanol: ammonia (3:2:0.5 v/v/v). This system was found to give compact spots for Sofosbuvir (R_f value–0.59). Densitometric analysis of Sofosbuvir was carried out in the absorbance mode at 261 nm. The linear regression analysis data for the calibration spots showed good relationship with (regression) r² = 0.9992 in the range of 300–1800 ng per band. The LOD and LOQ were 6.71 ng/band and 20.34 ng/band, respectively. The method was validated with respect to linearity, accuracy, precision, robustness and ruggedness. The proposed HPTLC method has been validated according to ICH guidelines and show high sensitivity, accuracy and precision.

Key words: Sofosbuvir; HPTLC; Method Validation