Rapid and selective determination of 9 nitrosamines in biological samples using ultra-high performance liquid chromatography-triple quadrupole linear ion trap mass spectrometry

Zhang, Hua; Huang, Alex Q.; Wu, Xianglun; Zhan, Bindong; Chen, Dongyang; Mei, Lei; Zhang, Hao

doi:10.1039/d2ay00468b

Cited by 2 publications

(1 citation statement)

References 30 publications

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“…In this study, a new methodology for trace determination of NAs in metronidazole benzoate (MB) is developed using high-performance LC/atmospheric-pressure chemical ionization tandem MS (HPLC-APCI-MS/MS). Multiple-reaction monitoring (MRM) scanning in the positive ionization mode was used to promote analytical selectivity and sensitivity while reducing interference and noise in the second quadruple detector [31][32][33]. HPLC-APCI-MS/MS with the MRM mode was recommended in Ph.…”

Section: Introductionmentioning

confidence: 99%

Method for trace determination of N‐nitrosamines impurities in metronidazole benzoate using high‐performance liquid chromatography coupled with atmospheric‐pressure chemical ionization tandem mass spectrometry

Yin

Fan

et al. 2022

J of Separation Science

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Genotoxic impurity control has been a great concern in the pharmaceutical industry since the recall of the large round of sartans worldwide in 2018. In these sartans, N-nitrosamines were the main contaminants in active pharmaceutical ingredients and formulations. Numerous analytical methods have been developed to detect N-nitrosamines in food, drugs, and environmental samples. In this study, a sensitive method is developed for the trace determination of N-nitrosamine impurities in metronidazole benzoate pharmaceuticals using high-performance liquid chromatography/atmospheric-pressure chemical ionization tandem mass spectrometry in the multiple reaction monitoring mode.The method was validated regarding system suitability, selectivity, linearity, accuracy, precision, sensitivity, solution stability, and robustness. The method showed good linearity with R 2 ≥ 0.999 and F Mandel < F tab(95%) ranging from 0.33 to 8.00 ng/ml. The low limits of detection of N-nitrosamines were in the range of 0.22-0.80 ng/ml (0.0014-0.0050 ppm). The low limits of quantification were in the range of 0.33-1.20 ng/ml (0.0021-0.0075 ppm), which were lower than the acceptable limits in metronidazole benzoate pharmaceuticals and indicated the high sensitivity of the method. The recoveries of N-nitrosamines ranged from 84% to 97%. Thus, this method exhibits good selectivity, sensitivity, and accuracy. Moreover, it is a simple, convenient, and scientific strategy for detecting N-nitrosamine impurities in pharmaceuticals to support the development of the pharmaceutical industry.

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Section: Introductionmentioning

confidence: 99%

Method for trace determination of N‐nitrosamines impurities in metronidazole benzoate using high‐performance liquid chromatography coupled with atmospheric‐pressure chemical ionization tandem mass spectrometry

Yin

Fan

et al. 2022

J of Separation Science

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A Novel Method for Monitoring N-Nitrosamines Impurities Using NH2-MIL-101(Fe) Mediated Dispersive Micro-Solid Phase Extraction Coupled with LC-MS/MS in Biopharmaceuticals

Xie

Zhang

Hou

et al. 2023

Journal of Pharmaceutical Sciences

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Rapid and selective determination of 9 nitrosamines in biological samples using ultra-high performance liquid chromatography-triple quadrupole linear ion trap mass spectrometry

Abstract: A sensitive, selective and convenient method for the simultaneous determination of 9 nitrosamines (NAs) in biologic samples was developed using isotope dilution ultra-high performance liquid chromatography-triple quadrupole linear ion trap...

Cited by 2 publications

References 30 publications

Method for trace determination of N‐nitrosamines impurities in metronidazole benzoate using high‐performance liquid chromatography coupled with atmospheric‐pressure chemical ionization tandem mass spectrometry

Method for trace determination of N‐nitrosamines impurities in metronidazole benzoate using high‐performance liquid chromatography coupled with atmospheric‐pressure chemical ionization tandem mass spectrometry

A Novel Method for Monitoring N-Nitrosamines Impurities Using NH2-MIL-101(Fe) Mediated Dispersive Micro-Solid Phase Extraction Coupled with LC-MS/MS in Biopharmaceuticals

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