- P-ISSN 2233-4203
- E-ISSN 2093-8950
- P-ISSN2233-4203
- E-ISSN2093-8950
- ESCI, SCOPUS, KCI
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Screening of Nitrosamine Impurities in Sartan Pharmaceuticals by GC-MS/MS
Screening of Nitrosamine Impurities in Sartan Pharmaceuticals by GC-MS/MS
Mass Spectrometry Letters / Mass Spectrometry Letters, (P)2233-4203; (E)2093-8950
2021, v.12 no.2, pp.31-40
https://doi.org/10.5478/MSL.2021.12.2.31
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
(Food and Drug Administration, Ministry of Health and Welfare)
Chang,
S.,
Ho,
H.,
Zang,
C.,
Hsu,
Y.,
Lin,
M.,
Tseng,
S.,
&
Wang,
D.
(2021). Screening of Nitrosamine Impurities in Sartan Pharmaceuticals by GC-MS/MS. Mass Spectrometry Letters, 12(2), 31-40, https://doi.org/10.5478/MSL.2021.12.2.31
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Abstract
Probable human carcinogenic compounds nitrosamines, have been detected as by-product impurities in sartan phar-maceuticals in recent years which has drawn worries for medication safety. To provide a sensitive and effective method for the quality control of sartan pharmaceuticals, this study established a feasible gas chromatography–tandem mass spectrometry (GC–MS/MS) method for simultaneous determination of 13 nitrosamines. The target analytes were separated on a DB-WAX Ultra Inert column (30 m × 0.25 mm; i.d., 0.25 µm) and were then subjected to electron impact ionization in multiple reaction moni-toring mode. The established method was validated and further employed to analyze authentic samples. Limits of detection (LODs) and limits of quantification (LOQs) of the 13 nitrosamines were 15-250 ng/g and 50-250 ng/g, respectively, which also exhibited intra-day and inter-day accuracies of 91.4-104.8%, thereby satisfying validation criteria. Five nitrosamines, viz., N-nitrosodiethylamine, N-nitrosodimethylamine, N-nitrosodiphenylamine, N-nitrosomorpholine, and N-nitrosopiperidine were detected at concentrations above their LODs in 68 positive samples out of 594 authentic samples from seven sartans.
- keywords
- angiotensin II type 1 receptor blockers, carcinogens, gas chromatography, mass spectrometry, nitrosamines
- 투고일Submission Date
- 2021-04-22
- 수정일Revised Date
- 2021-05-11
- 게재확정일Accepted Date
- 2021-05-18
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