Determination of nitrobenzene potential genotoxic impurities in nifedipine with GC-MS.
J Pharm Biomed Anal
; 248: 116274, 2024 Sep 15.
Article
de En
| MEDLINE
| ID: mdl-38852298
ABSTRACT
There is an increasing scientific interest in the detection of genotoxic impurities (GTIs), with nitrobenzene compounds being considered potential genotoxic impurities due to their structural alerts, which demonstrates a threat to drug safety for patient. While current reports on the detection of nifedipine impurity primarily focus on general impurities in nifedipine. In this study, an effective and simple gas chromatography-mass spectrometry (GC-MS) method was established and verified for the separation and quantification of 2-nitrotoluene, 2-nitrobenzyl alcohol, 2-nitrobenzaldehyde, 3-nitrobenzaldehyde, 4-nitrobenzaldehyde, and 2-nitrobenzyl bromide in nifedipine, which have not been previously reported. The validation of this GC-MS method was conducted following the International Conference of Harmonization (ICH) guidelines, exhibiting good linearity within the range of 2-40⯵g/g and accuracy between 84.6â¯% and 107.8â¯%, the RSD% of intra-day and inter-day precision was in the range of 1.77-4.55â¯%, stability and robustness also met acceptance criteria. This method filled the gap in detection method for nitrobenzene compounds in nifedipine, offering a novel method and technical support for nifedipine quality control.
Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Nifédipine
/
Contamination de médicament
/
Chromatographie gazeuse-spectrométrie de masse
/
Nitrobenzènes
Langue:
En
Journal:
J Pharm Biomed Anal
Année:
2024
Type de document:
Article
Pays d'affiliation:
Chine
Pays de publication:
Royaume-Uni