2. Academic Validation
  3. Identification and characterization of new impurities in zopiclone tablets by LC-QTOF-MS

Identification and characterization of new impurities in zopiclone tablets by LC-QTOF-MS

  • J Pharm Biomed Anal. 2021 May 30;199:114056. doi: 10.1016/j.jpba.2021.114056.
Xing Han 1,  Fang-Jie Cheng 1,  Bin Di 1,  Hui Xu 2,  Min Song 1,  Tai-Jun Hang 3,  Yu-Ting Lu 4
Affiliations

Affiliations

  • 1 China National Narcotics Control Commission-China Pharmaceutical University Joint Laboratory on Key Technologies of Narcotics Control, China; Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.
  • 2 China National Narcotics Control Commission-China Pharmaceutical University Joint Laboratory on Key Technologies of Narcotics Control, China.
  • 3 China National Narcotics Control Commission-China Pharmaceutical University Joint Laboratory on Key Technologies of Narcotics Control, China; Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China. Electronic address: hangtj@cpu.edu.cn.
  • 4 China National Narcotics Control Commission-China Pharmaceutical University Joint Laboratory on Key Technologies of Narcotics Control, China; Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China. Electronic address: luyt@cpu.edu.cn.
PMID: 33831736 DOI: 10.1016/j.jpba.2021.114056
Abstract

Zopiclone, a non-benzodiazepine hypnotic, is the first-line treatment for insomnia. The quality and stability of zopiclone tablets directly affects its efficacy and safety. However, the impurity investigation in zopiclone tablets remain incomplete. In this study, the accelerated and long-term stabilities of zopiclone tablets, as well as the stability characteristics under thermal and photolytic conditions were evaluated according to the ICH guidelines. In addition, a sensitive and specific LC-QTOF-MS method was developed for the separation and identification of all the impurities in zopiclone tablets and its stability test samples. Nine impurities were found in the test samples, five among them have not been reported before. Based on the accurate mass and elemental compositions of the parent and product ions obtained, the structures of all the detected impurities were identified. Combined with the formulation composition analysis and stability studies, the origins and the formation mechanisms of these impurities were elucidated. The obtained results are useful for the establishment of the optimum formulation, storage condition, manufacturing processes and quality control of zopiclone tablets.

Keywords

Impurities; Stability; Zopiclone tablets.

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