TY - JOUR AU - Annapurna, Mukthinuthalapati Mathrusri PY - 2018/05/14 Y2 - 2024/03/29 TI - New Stability Indicating Ultrafast Liquid Chromatographic Method for the Determination of Sofosbuvir in Tablets JF - Asian Journal of Pharmaceutics (AJP) JA - AJP VL - 12 IS - 01 SE - ORIGINAL ARTICLES DO - 10.22377/ajp.v12i01.2053 UR - https://asiapharmaceutics.info/index.php/ajp/article/view/2053 SP - AB - <p>Introduction: To develop a new sensitive, precise, simple, and economic stability indicating reverse phaseultrafast<br />liquid chromatographic (RP-UFLC) method for the estimation of Sofosbuvir (SFB) in bulk and<br />its tablet dosage forms. Materials and Methods: Chromatographic separation was achieved through C8<br />Phenomenex column (250 mm × 4.6 mm i.d., 5 μm particle size) using acetonitrile: 0.1% Formic acid mixture<br />as the mobile phase. The Shimadzu model CBM-20A/20 Elite high-performance liquid chromatography<br />system was monitored at detection wavelength 259 nm in isocratic mode with flow rate 0.8mL/min and<br />the total run time is 10 min. The method was validated, and forced degradation studies were conducted.<br />Results and Discussion: SFB has obeyed Beer-Lambert’s law over a concentration range 1–200 μg/<br />mL with correlation coefficient 0.9998. The limit of detection and limit of quantification are found to be<br />0.2541 μg/ mL and 0.7642 μg/mL, respectively. The percentage relative standard deviation in precision and<br />accuracy studies was found to be &lt;2% and the percentage recovery is 98.11–98.78%. SFB was found to<br />be highly sensitive toward alkaline conditions. Conclusions: It is observed that this RP-UFLC method is<br />accurate, precise, sensitive, and reproducible for the estimation of SFB in tablets. The method was validated<br />as per the ICH guidelines and very much specific as the degradants were well separated without interfering<br />the drug peak.</p> ER -