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 7 Results of robustness for change in chromatographic parameters

Modification in chromatographic conditions	Retention time (min)		Plate count		Tailing factor		% RSD		Reso	Retention time from sample
Modification in chromatographic conditions	TLS	RST	TLS	RST	TLS	RST	TLS	RST	Reso	TLS	RST
As per method	2.553	4.505	2917	8288	1.44	1.23	1.67	1.52	9.40	2.548	4.493
Flow rate − 0.1 mL/min	2.974	4.919	2804	8564	1.41	1.24	0.46	0.76	8.55	2.856	4.974
Flow rate + 0.1 mL/min	2.326	4.075	2746	7911	1.38	1.22	0.54	0.65	9.11	2.322	4.076
Organic phase − 10%	2.737	5.299	3226	8411	1.50	1.25	0.59	1.06	11.41	2.599	5.352
Organic phase + 10%	2.096	3.944	2986	6733	1.41	1.22	0.73	0.85	10.15	2.057	3.915
Buffer phase − 10%	2.095	4.047	2536	7191	1.48	1.22	0.51	0.58	10.93	2.108	4.000
Buffer phase + 10%	2.722	5.219	3070	9911	1.40	1.19	0.54	0.70	11.65	2.575	5.313
pH of buffer − 0.2	2.041	4.435	2762	8118	1.30	1.20	0.27	1.19	12.86	2.095	4.397
pH of buffer + 0.2	2.850	4.352	2630	7622	1.52	1.24	1.00	0.74	6.73	2.686	4.400
Quantity of PDP − 10%	2.376	4.632	2764	7875	1.53	1.22	0.32	0.66	11.16	2.340	4.593
Quantity of PDP + 10%	2.384	4.588	3038	6916	1.47	1.24	0.62	0.52	10.05	2.468	4.531
Quantity of OSASS − 10%	2.370	4.432	2961	7251	1.46	1.24	1.15	0.83	10.01	2.356	4.417
Quantity of OSASS + 10%	2.456	4.421	2879	7066	1.43	1.20	0.50	0.89	9.46	2.487	4.505
Acceptance criteria	–	–	> 2000		NMT 2.0		≤ 2.0		NLT 2.0	Similar to standard