Profiling of genotoxic impurities in a lidocaine hydrochloride injection

XIAN Zhiran; SUN Chunmeng; LUO Xuefang; ZHONG Wenying

doi:10.11665/j.issn.1000-5048.20200412

Journal of China Pharmaceutical University > 2020 > 51(4): 466-471. > DOI: 10.11665/j.issn.1000-5048.20200412

XIAN Zhiran, SUN Chunmeng, LUO Xuefang, ZHONG Wenying. Profiling of genotoxic impurities in a lidocaine hydrochloride injection[J]. Journal of China Pharmaceutical University, 2020, 51(4): 466-471. DOI: 10.11665/j.issn.1000-5048.20200412

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Profiling of genotoxic impurities in a lidocaine hydrochloride injection

1.
Drug Quality Research Center, College of Science, China Pharmaceutical University
2.
School of Pharmacy, China Pharmaceutical University, China

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Received Date: March 19, 2020

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- lidocaine hydrochloride injection,
- genotoxic impurities,
- LC-MS/MS

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[3]	Wang X, Li X, Xiao Y. A novel dispersive liquid-liquid microextraction method with high performance liquid chromatography for detection of 2,6-dimethylaniline in lidocaine hydrochloride injection[J]. Se Pu,2018,36(3): 292-298.doi: 10.3724/SP.J.1123.2017.11049.
[4]	Deng ZH, Li AH, Hu WJ. Improvement of quality control of lidocaine hydrochloride injection[J]. J Pharm Pract（药学实践杂志）,2016(1):72-75.doi: 10.3969/j.issn.1006-0111.2016. 01. 019.
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[8]	Yang RY, Yin XL, Liang M, et al. Microscale experimental study on preparation of lidocaine[J]. Guangdong Chem Ind（广东化工）,2010,37 (5):137, 149.doi: 10.3969/j.issn.1007-1865.2010.05.058.
[9]	Zhejiang Huineng Biological Co., Ltd. Method for preparing lidocaine hydrochloride： 201510738390.7[P].2016-02-03.
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[11]	Li M. Organic Chemistry of Drug Degradation[M]. United Kingdom: CPI Group (UK) Ltd, Croydon, CR04YY, UK,2012.
[12]	Li Q, Magers T, King B, et al. Measurement of lidocaine and 2,6-dimethylaniline in minipig plasma, skin, and dermal tapes using UHPLC with electrospray MS/MS[J]. J Chromatogr B Analyt Technol Biomed Life Sci,2018,1087-1088:158-172. doi: 10.1016/j.jchromb.2018.04.030.
[13]	Kobets T, Duan JD, Brunnemann KD, et al. DNA-damaging activities of twenty-four structurally diverse unsubstituted and substituted cyclic compounds in embryo-fetal chicken livers[J]. Mutat Res, 2019,844:10-24.doi: 10.1016/j.mrgentox.2019.06.004.
[14]	Koujitani T., Yasuhara K., Kobayashi H., et al. Tumor‐promoting activity of 2,6‐dimethylaniline in a two‐stage nasal carcinogenesis model in N‐bis(2‐hydroxypropyl) nitrosamine‐treated rats[J]. Cancer Lett, 1999,142(2):161-171.
[15]	The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Trepartite Guideline: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7(R1) [S/OL]. (2017-05-01) [2019-01-28]. https://www.ich.org/fileadmin/.
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