New Stability Indicating Ultrafast Liquid Chromatographic Method for the Determination of Sofosbuvir in Tablets

Abstract

Introduction: To develop a new sensitive, precise, simple, and economic stability indicating reverse phaseultrafast
liquid chromatographic (RP-UFLC) method for the estimation of Sofosbuvir (SFB) in bulk and
its tablet dosage forms. Materials and Methods: Chromatographic separation was achieved through C8
Phenomenex column (250 mm × 4.6 mm i.d., 5 μm particle size) using acetonitrile: 0.1% Formic acid mixture
as the mobile phase. The Shimadzu model CBM-20A/20 Elite high-performance liquid chromatography
system was monitored at detection wavelength 259 nm in isocratic mode with flow rate 0.8mL/min and
the total run time is 10 min. The method was validated, and forced degradation studies were conducted.
Results and Discussion: SFB has obeyed Beer-Lambert’s law over a concentration range 1–200 μg/
mL with correlation coefficient 0.9998. The limit of detection and limit of quantification are found to be
0.2541 μg/ mL and 0.7642 μg/mL, respectively. The percentage relative standard deviation in precision and
accuracy studies was found to be <2% and the percentage recovery is 98.11–98.78%. SFB was found to
be highly sensitive toward alkaline conditions. Conclusions: It is observed that this RP-UFLC method is
accurate, precise, sensitive, and reproducible for the estimation of SFB in tablets. The method was validated
as per the ICH guidelines and very much specific as the degradants were well separated without interfering
the drug peak.