Qualitative and quantitative determination of a new impurity from beclomethasone propionate inhalation aerasol
10.12173/j.issn.2097-4922.202403196
- VernacularTitle:丙酸倍氯米松吸入气雾剂中新杂质的定性定量分析
- Author:
Cong DAI
1
;
Heng TIAN
;
Chunmin WU
;
Yixue YANG
;
Qihua BEI
;
Quanhong YAN
Author Information
1. 广东省药品检验所(广州 510663)
- Keywords:
Beclomethasone propionate inhalation aerasol;
Ultra-performance liquid chromatography-Q-exactive orbitrap-mass spectrometry;
Discovery Studio software;
New impurity;
Identification;
Toxicity prediction;
Content determination
- From:
China Pharmacist
2024;28(11):416-423
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a method to qualitatively identify and quantitatively determine a new impurity from beclomethasone propionate inhalation aerasol.Methods Ultra-performance liquid chromatography-Q-exactive orbitrap-mass spectrometry(UPLC-QE-MS)technology and Discovery Studio software were used to identify and predict the toxicity of a new impurity in beclomethasone propionate inhalation aerasol,and the content of this new impurity was determined by UPLC.Results The new impurity in beclomethasone propionate inhalation aerasol was polybutylene terephthalate(PBT)cyclic dimer.Discovery Studio software predicted that PBT dimer had potential developmental toxicity,with no mutagenicity,no ocular and skin irritancy and no rodent carcinogenicity.The content range of PBT dimer in 9 batches of beclomethasone propionate inhalation aerasol was 20.5-116.6 pg per bottle.Conclusion This study can realize the rapid identification and toxicity prediction of the new impurity in the preparation,and provide a theoretical basis for the quality control of the preparation by determining their content.
