Stability-indicating RP-HPLC method development and validation for simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and in tablet dosage form

Future Journal of Pharmaceutical Sciences

Table 3 Results of forced degradation study

Sample name/stress condition	Drug substance						Drug product
	% Assay		% Total degradation		% Mass Balance		% Assay		% Total degradation		% Mass Balance
	TLS	RST	TLS	RST	TLS	RST	TLS	RST	TLS	RST	TLS	RST
Unstressed (as per method)	99.74	98.70	ND	ND	99.74	98.70	98.14	98.74	ND	ND	98.14	98.74
Acid/5 N HCl/ 3 h/RT	98.72	81.82	ND	18.25	98.72	100.07	98.96	85.25	ND	15.80	98.96	101.04
Alkali/5 N NaOH/3 h/RT	99.82	98.23	ND	ND	99.82	98.23	100.44	101.15	ND	ND	100.44	101.15
Oxidative/6% H₂O₂/3 h/RT	99.16	99.87	ND	ND	99.16	99.87	99.52	99.15	ND	ND	99.52	99.15
Thermal/105 °C/24 h	98.94	98.19	ND	ND	98.94	98.19	98.25	62.72	ND	35.05	98.25	97.77
Photolytic/UV light/24 h	99.02	95.06	ND	2.62	99.02	97..68	98.37	85.52	ND	12.09	98.37	97.61
Humidity/75% RH/ 48 h	98.69	97.91	ND	ND	98.69	97.91	99.03	99.18	ND	ND	99.03	99.18