VALIDATED STABILITY-INDICATING HPTLC METHOD FOR THE DETERMINATION OF PROPAFENONE HYDROCHLORIDE IN TABLETS AND THE GC-MS IDENTIFICATION OF ITS DEGRADATION PRODUCTS

A novel stability-indicating TLC method for determination of propafenone hydrochloride (PRO) in bulk drug and POLFENON tablets. Normal-phase high performance thin layer chromatographic separation was achieved by use of silica gel 60F(254) plates and mixture of chloroform-methanol-acetic acid 99.5% (7.9:2:0.1, v/v/v) as the mobile phase. Linear calibration function was obtained (r(2)=0.9987) with respect to peak area in the concentration range of 0.1-3.2 mu g/spot. Densitometric analysis of PRO and its forced-degradation products was carried out in the absorbance mode at 316nm. Limits of detection and quantification were 0.02 and 0.08 mu g/spot, respectively. PRO was subjected to stress conditions for obtainment of hydrolytic, oxidative, photolytic, and thermal degradation products. The GC-MS technique was applied to identification of the degradants. The elaborated method was validated using ICH guidelines. The linearity, accuracy (99.24%), precision (intraday RSD 1.61%), and specificity were satisfactory. The validated stability indicating method enables reproducible and selective analysis of propafenone hydrochloride in pharmaceutical dosage form.