Development of stability-indicating HPLC method for quantification of pharmacopeia impurities of Zuclopenthixol and characterization of its stress degradation products by LCMS/MS

Future Journal of Pharmaceutical Sciences

Table 2 Results observed in robustness study

S.no.	Changed condition	Parameter	Results observed
S.no.	Changed condition	Parameter	Zuclopenthixol	Impurity A	Impurity B
1	MP 1	% change	1.23	0.23	0.32
		t_R	6.91	2.89	1.99
		N	8354	4498	3592
2	MP 2	% change	0.15	0.09	0.07
		t_R	6.92	2.87	1.91
		N	8493	4528	3697
3	pH 1	% change	0.17	0.06	0.08
		t_R	6.95	2.85	1.95
		N	8362	4499	3708
4	pH 2	% change	0.29	0.16	0.03
		t_R	6.98	2.88	1.93
		N	8473	4618	3791
5	WL 1	% change	0.40	0.48	0.85
		t_R	6.99	2.82	1.97
		N	8496	4566	3581
6	WL 2	% change	0.54	0.66	0.61
		t_R	6.93	2.84	1.92
		N	8320	4403	3528
7	CT 1	% change	1.23	0.23	0.32
		t_R	6.91	2.89	1.99
		N	8354	4498	3592
8	CT 2	% change	0.15	0.09	0.07
		t_R	6.92	2.87	1.91
		N	8493	4528	3697

MP (mobile phase) 1: 45:55 (v/v) of solvent A and B; MP 2: 55:45 (v/v) of solvent A and B; pH 1: 4.2; pH 2: 4.4; WL (wavelength) 1: 252 nm; WL 2: 262 nm; CT (column temperature) 1: 32 °C; CT 2: 38 °C. ^$average results (n = 3)