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Study of the impurity profile of photodegradation in lomefloxacin hydrochloride ear drops using liquid chromatography combined with ion trap/time-of-flight mass spectrometry.
Zeng, Hongxia; Yang, Ying; Gao, Jiarui; Zhou, Yuping; Zheng, Jinqi.
Afiliación
  • Zeng H; Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration & Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Zhejiang Institute for Food and Drug Control, Hangzhou, China.
  • Yang Y; China Jiliang University, Hangzhou, China.
  • Gao J; Zhejiang University of Technology, Hangzhou, China.
  • Zhou Y; Zhejiang University of Technology, Hangzhou, China.
  • Zheng J; Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration & Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Zhejiang Institute for Food and Drug Control, Hangzhou, China.
Rapid Commun Mass Spectrom ; 38(10): e9732, 2024 May 30.
Article en En | MEDLINE | ID: mdl-38525499
ABSTRACT
RATIONALE Lomefloxacin hydrochloride ear drops are highly unstable to light and prone to produce photodegradation impurities. These impurities might be related to the phototoxicity of lomefloxacin, which could seriously threaten the health of patients. In this article, the photodegradation impurity profile in lomefloxacin hydrochloride ear drops was studied for further improvement of quality control of the drug.

METHODS:

By studying the chromatographic behavior of photodegradation impurities, the photodegradation impurities in lomefloxacin hydrochloride ear drops were separated and detected effectively. Liquid chromatography combined with ion trap/time-of-flight mass spectrometry was applied to characterize the structures of the photodegradation impurities in lomefloxacin hydrochloride ear drops.

RESULTS:

The structures of 17 impurities in lomefloxacin hydrochloride ear drops were elucidated based on high-resolution MSn data in positive ion mode, 12 of them being unknown impurities.

CONCLUSIONS:

The structural characteristics and fragmentation patterns of the photodegradation impurities were also studied. The study of the photodegradation impurity profile in lomefloxacin hydrochloride ear drops provides a scientific basis for quality control of these ear drops and ensures the safety of drug use by the public.
Asunto(s)

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Contaminación de Medicamentos / Fluoroquinolonas Límite: Humans Idioma: En Revista: Rapid Commun Mass Spectrom Año: 2024 Tipo del documento: Article País de afiliación: China

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Contaminación de Medicamentos / Fluoroquinolonas Límite: Humans Idioma: En Revista: Rapid Commun Mass Spectrom Año: 2024 Tipo del documento: Article País de afiliación: China