Development and Validation of a Stability Indicating RP-UPLC Method for Analysis of Imipramine Hydrochloride in Pharmaceuticals

Table 6

Method robustness.

Condition	Modification	Mean peak area ± SD*	% RSD	Mean Rt ± SD	% RSD	Mean theoretical plates ± SD*	% RSD	Mean tailing factor ± SD	% RSD
Temperature (°C)	20	147204 ± 105.0	0.88	2.01 ± 0.01	0.55	2976 ± 43	1.43	1.101 ± 0.004	0.35
	25	147271 ± 157.2	1.09	2.12 ± 0.02	0.72	3067 ± 59	1.94	1.117 ± 0.003	0.23
	30	147144 ± 156.3	1.52	1.99 ± 0.01	0.33	3119 ± 64	2.07	1.108 ± 0.003	0.24
Mobile phase composition	70 : 30	147371 ± 147.3	0.84	2.01 ± 0.01	0.57	2979 ± 28	0.96	1.020 ± 0.003	0.29
	75 : 25	147304 ± 260.8	1.32	2.12 ± 0.01	0.47	3040 ± 52	1.68	1.110 ± 0.001	0.32
	85 : 15	147511 ± 295.1	1.68	2.00 ± 0.01	0.36	3119 ± 65	2.07	1.050 ± 0.007	0.67
Flow rate	0.25	147307 ± 110.15	0.63	1.99 ± 0.004	0.23	3079 ± 12	0.39	1.110 ± 0.004	0.36
	0.30	147171 ± 163.7	0.42	2.11 ± 0.005	0.24	3104 ± 8	0.16	1.110 ± 0.004	0.34
	0.35	147211 ± 110.00	0.76	2.11 ± 0.0606	0.26	3129 ± 12	0.41	1.108 ± 0.003	0.28
Wavelength	218 nm	147341 ± 163.71	0.34	2.12 ± 0.003	0.14	3019 ± 24	0.81	1.124 ± 0.005	0.45
	220 nm	147218 ± 215.48	0.38	2.11 ± 0.003	0.12	3169 ± 26	0.84	1.117 ± 0.003	0.23
	222 nm	147254 ± 58.59	0.48	2.12 ± 0.004	0.17	3153 ± 30	0.95	1.106 ± 0.005	0.46

  *Mean value of three determinations.