Development of a sensitive and stable GC-MS/MS method for simultaneous determination of four N-nitrosamine genotoxic impurities in sartan substances

Journal of Analytical Science and Technology

Table 4 Calibration curves, LODs, and LOQs for four N-nitrosamines

Analyte	Linearity range (ng·mL⁻¹)	Regression equation	R²	Methanol		Candesartan cilexetil		Olmesartan medoxomi		Irbesartan		Valsartan
				LOD	LOQ	LOD	LOQ	LOD	LOQ	LOD	LOQ	LOD	LOQ
				(ng·mL⁻¹)		(ppm)
NDMA	3.0-60	y = 0.0114x−0.0034	0.9968	1.2	3.0	0.120	0.300	0.120	0.300	0.012	0.030	0.012	0.030
NDEA	0.8-16	y = 0.0130x−0.0032	0.9926	0.2	0.8	0.020	0.080	0.020	0.080	0.002	0.008	0.002	0.008
NDIPA	3.0-60	y = 0.0112x−0.0004	0.9977	0.4	1.0	0.040	0.100	0.040	0.100	0.004	0.010	0.004	0.010
NDBA	6.0-60	y = 0.0038x + 0.0022	0.9947	1.5	5.0	0.150	0.500	0.150	0.500	0.015	0.050	0.015	0.050