摘要
加巴喷汀是美国Warner-Lanbert公司首先开发的抗癫痫药,是γ-氨基丁酸(GABA)的衍生物,于1993年首次在英国上市。其生产中的残留溶媒包括二氯甲烷、甲醇、乙醇、乙酸乙酯和异丙醇应进行严格控制。使用气相色谱法,采用顶空进样,参照ICH中Q3C对残留溶剂的要求,对加巴喷汀中的残留溶媒分析方法进行验证。验证结果表明,本方法精密度高,线性良好,能够满足药品质量控制的需要。
Gabapentin is an anti-epilepsy drug and a gamma aminobutyric acid.It was first developed by Warner-l.anbert in the USA, it was first listed in UK in 1993. In gabapentin production,there were some residual solvents including dichloromethane, methanol, ethanol, ethyl acetate and isopropyl alcohol in the product, so they should be controlled strictly. According to Q3c of the ICH about the residual solvents, the analysis method of the residual solvents of gabapentin was validated by gas chromatography with headspace sampling. The validation results showed that the method had high precision and good linearity, could meet the needs of quality control of drugs.
出处
《煤炭与化工》
CAS
2014年第8期87-89,共3页
Coal and Chemical Industry
关键词
加巴喷汀
气相色谱法
残留溶媒
测定
gabapentin
bgas chromatography
residual solvent
measure
