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  • P-ISSN2233-4203
  • E-ISSN2093-8950

Screening of Nitrosamine Impurities in Sartan Pharmaceuticals by GC-MS/MS

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
Shu-Han Chang (Food and Drug Administration, Ministry of Health and Welfare)
Hui-Yu Ho (Food and Drug Administration, Ministry of Health and Welfare)
Chi-Zong Zang (Food and Drug Administration, Ministry of Health and Welfare)
Ya-Hui Hsu (Food and Drug Administration, Ministry of Health and Welfare)
Mei-Chih Lin (Food and Drug Administration, Ministry of Health and Welfare)
Su-Hsiang Tseng (Food and Drug Administration, Ministry of Health and Welfare)
Der-Yuan Wang (Food and Drug Administration, Ministry of Health and Welfare)

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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.

Submission Date
2021-04-22
Revised Date
2021-05-11
Accepted Date
2021-05-18

Mass Spectrometry Letters