Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, India
A new stability indicating RP-UFLC method has been proposed for the determination of Tilorone in bulk and its tablet dosage forms. 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 asmobile phase. The UFLC system was monitored at 270 nm on isocratic mode withflow rate 0.5 mL/min and the total run time is 10mins. The method was validated and forced degradation studies were performed. Tilorone has obeyed Beer-Lambert's law0.1–20 μg/mL with correlation coefficient 0.9999. The LOD and LOQare found to be 0.0104and 0.0316 μg/mL respectively. Tiloronewas subjected to stress degradationstudies. The UFLC method is accurate, precise, sensitive, and reproducible forthe estimation of Tiloronein tablets. The method was validated as per ICH guidelines and found to be specific as the degradants were well separated without interfering with the drug peak.
Tilorone, Stability Indicating, UFLC, ICH guidelines
