Affiliation:
1. State Key Laboratory of Pharmaceutical Biotechnology, Medical School of Nanjing University & School of Life Sciences, Nanjing University, Nanjing, China | Institute of Drug R&D, Nanjing University, Nanjing, China
Abstract
Background:
(S)-oxiracetam has shown better efficacy than racemic oxiracetam in the
trial. However, there is no report on the method used to detect the genotoxic impurity of S-(+)-
epichlorohydrin(S-(+)-ECH) that may be contained in (S)-oxiracetam.
Objective:
Here, we have proposed and verified a detailed analysis method for the (S-(+)-ECH)
impurity in (S)-oxiracetam using a gas chromatography(GC) system.
Method:
The chromatography system includes a Supelco DB-624 capillary column. The initial
column temperature was 50°C, kept for 4 minutes, and then increased to 220°C at a rate of
10°C/min for 4 minutes. Nitrogen was used as the carrier gas. The constant flow rate was 3.8
mL/min, the split ratio was 10:1, the injection port temperature was maintained at 200°C, and a
hydrogen flame ionization detector was used. S-(+)-ECH was analyzed in detail by this analysis
method, and three different batches of samples were measured. The GC system was used for verification.
Results:
The method verification results included the system suitability, specificity, sensitivity,
accuracy, precision, and the good correlation coefficient between peak responses and concentrations
were over 0.990.
Conclusion:
The method proposed in this study is the most detailed GC method currently used
for the analysis of S-(+)-ECH impurities in (S)-oxiracetam. The proposed method has the advantages
of fast, convenience, low cost, etc. It provides a reference method for quality control of
genotoxic impurity of (S)-oxiracetam.
Funder
National Natural Science Foundation of China
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献