Development of validated stability-indicating chromatographic method for the determination of fexofenadine hydrochloride and its related impurities in pharmaceutical tablets

Table 4 Summary of degradation studies of FEX using the proposed HPLC method*

	% Recovery	Purity angle	Purity threshold	Match angle	Match threshold	t_Rvaluesof degradation products
Acid-induced degradation (0.5 N HCl, 80°C, 4 hr)	82.51	0.130	0.347	0.069	1.079	17.48, 19.62, 26.40
Base-induced degradation (0.5 N NaOH, 80°C, 4 hr)	89.54	0.145	0.425	0.081	1.105	-
Oxidative degradation	89.73	0.125	0.332	0.084	1.071	-
-3% H₂O₂
(80°C, 2 hr)
-30% H₂O₂ (80 s°C, 2 hr)	22.01	0.145	0.352	0.035	1.077	11.83
Photochemical degradation	98.89	0.121	0.341	0.111	1.076	-
-Direct daylight
(7 days)
-UV at 254 nm (8 hr)	98.66	0.111	0.342	1.076	1.098	-
Thermal degradation (80°C, 8 hr)	98.40	0.118	0.411	0.101	1.098	-

*FEX peak was defined as main peak since match angle was less than match threshold and also as pure peak since purity angle was less than purity threshold under all forced tests.

ISSN: 2661-801X