VALIDATED STABILITY-INDICATING RP-UHPLC METHOD FOR THE ESTIMATION OF SOFALCONE IN DRUGS, RECONCILING MASS BALANCE IN FORCE DEGRADATION STUDIES AND LC-MS IDENTIFICATION OF ITS DEGRADATION PRODUCTS

A highly sensitive, simple, accurate and precise Ultra high-performance liquid chromatographic (UHPLC) method was developed and validated for the quantitative determination of sofalcone in the presence of its degradation products. The analysis was performed on Agilent symmetry analytical column Eclipse plus C18 (100mm × 2.1 mm, 1.8μm) ultra-performance liquid chromato-graphy-Diode Array Detectors (UHPLCDAD), while the detection was performed on 350 nm using Diode Array Detectors. Water (0.1% Formic Acid) and Ammonium Acetate in Methanol were the mobile phases, run at a flow rate of 0.3 ml/min for gradient elution. The mean values of recovery were found to be 100.02% and 100.55%. The linear regression data for the calibration plot showed a good relationship with high correlation coefficients. The performance of the method was validated for precision, accuracy and robustness. Sofalcone was subjected to the ICH-prescribed acidic, alkaline, oxidative, photolytic, and thermal stress conditions, and it undergoes degradation with well-resolved degradation products. These degradation products were further analyzed by mass spectrometry to elucidate the structure of degradation products and proposed the prediction of the degradation pathway and Mass Balance.