Environmentally Friendly Analytical Methods for Quantitative Measurement of Sofosbuvir in Pharmaceutical Formulations: Comparison of HPTLC and UV Spectrophotometric Approaches

Abstract

For the quantitative measurement of sofosbuvir (SFR) in pharmaceutical formulation, high-performance thin-layer chromatographic (HPTLC) and environmentally friendly UV spectrophotometric approaches have been developed. HPTLC stationary phases were silica gel 60 F₂₅₄-coated aluminium plates. Toluene, chloroform, and ethanol were mixed 4:4:1 v/v/v. This mobile phase produced tiny spots of SFR with Rf 0.30±0.01. SFR was densitometrically analysed at 267nm in absorbance mode. Peak area showed great linearity (r2 =0.998) in the dilution range of 100–800ng/spot. A solvent combination of methanol and water was utilised for the UV spectrophotometric technique. First, a stock solution of SFR was made in methanol, and then it was diluted further in water. Absorption maxima were observed at 261nm for the SFR standard solution. Beer-law Lambert's was followed by the SFR at an r2 value of 0.999 at 10-50ng/mL. Both methods met ICH standards for precision, LOD, LOQ, accuracy and specificity. Statistical study validated the methods as reliable and accurate for the estimation of the SFR. The established procedures can be applied to the regular analysis of SFR drugs and pharmaceuticals.