New stability indicating ultrafast liquid chromatographic method for the determination of umifenovir in tablets

Abstract

Introduction: A new stability indicating RP-UFLC method was proposed for the determination of Umifenovir in bulk and its tablet dosage forms. Materials and Methods: Chromatographic separation was achieved through C18 Agilent column(150 mm × 4.6 mm i.d., 3.5 μm particle size) using acetonitrile: 0.1% triethylamine (pH adjusted to 3.2 with orthophosphoric acid) mixture as the mobile phase. The UFLC system was monitored at 223 nm on isocratic mode with flow rate 0.6 mL/min and the total run time is 10 min. The method was validated, and forced degradation studies were performed. Results and Discussion: Umifenovir has obeyed Beer-Lambert’s law over a concentration range 0.05–50 μg/mL with correlation coefficient 0.9997. The limit of detection and limit of quantification are found to be 0.0156 and 0.0421 μg/mL, respectively. Umifenovir was found to be highly sensitive toward alkaline conditions. Conclusions: It is observed that this reverse phase UFLC method is accurate, precise, sensitive, and reproducible for the estimation of Umifenovir 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.