Development and validation of a stability-indicating RP-HPLC method for simultaneous estimation of Gimeracil, Oteracil, and Tegafur in bulk and dosage forms in the presence of stress degradation impurities

In this study, an efficient, reproducible, and reliable stability indicating reverse-phase high-performance liquid chromatography (HPLC) method has been developed for the simultaneous quantification of Tegafur (TGFR), Gimeracil (GMRL), and Oteracil (ORCL) in bulk and dose formulation with a shorter run time (6min).TFGR, GMRL, and ORCL were separated using an isocratic method on a Waters C18 (250 mm × 4.6 mm × 5 μm) column with a mobile phase containing methanol and phosphate buffer (0.1M KH₂PO₄, pH 4.0) in a 50:50 (v/v) ratio. The detection wavelength was 275 nm and the flow rate was 1 mL/min. The new method demonstrated excellent linearity for TFGR (10 to 30μg/ml), GMRL (2.9 to 8.7μg/ml), and ORCL (7.9 to 23.70μg/ml). The method was found to be precise and accurate, with an RSD of 0.057% to 0.183% and a recovery rate of 98.66% to 100.52%. Stress degradation experiments have demonstrated that this method can be utilized to estimate TFGR, GMRL, and ORCL in the presence of their degradants. The method is suitable for determining TFGR, GMRL, and ORCL in bulk and capsule formulation (Tegonat).