Dynamic extraction of residual solvents from pharmaceutical formulations using a needle-type extraction device.

IF 1.8 4区 化学 Q3 CHEMISTRY, ANALYTICAL
Ikuo Ueta, Daisuke Kondo, Suguru Masuda, Yuki Ariizumi, Ryosuke Kikuchi, Koki Nakagami, Yoshihiro Saito
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引用次数: 0

Abstract

This study developed a rapid screening method to determine residual solvents contained in a tablet formulation using a needle-type extraction device. For this, the tablet formulation was pulverized and the powdered sample was rapidly inserted into a pipette tip. After fixing the sample with quartz wool, the pipette tip was capped with a silicon septum. A needle-type extraction device packed with Carbopack X and a carbon molecular sieve was inserted into the pipette tip through the septum, and the gas sample was collected. During this gas sampling, pure N2 gas was introduced into the pipette tip. The extraction time for collecting 100 mL of the sample was approximately 10 min. After gas sampling, the extraction needle was connected to a gas-tight syringe and 0.5 mL of pure N2 gas (desorption gas) was collected. The extraction needle was then inserted into a heated gas chromatographic injection port. The extracted residual solvents were then thermally desorbed and determined using a gas chromatograph-flame ionization detector. The detector response is very low for carbon tetrachloride, although the proposed method showed sufficient sensitivity for five Class 1 compounds. Additionally, this study clearly indicated that the purge efficiency of residual solves with dynamic extraction is different between powdered pharmaceutical formulations.

使用针式萃取装置动态萃取药物制剂中的残留溶剂。
本研究开发了一种快速筛选方法,利用针式萃取装置测定片剂配方中含有的残留溶剂。为此,先将片剂制剂粉碎,然后将粉末状样品快速插入移液器吸头。用石英棉固定样品后,用硅胶隔膜盖住移液器吸头。将装有 Carbopack X 和碳分子筛的针式萃取装置通过隔膜插入移液管吸头,收集气体样品。在气体采样过程中,将纯净的 N2 气体引入移液器顶端。收集 100 毫升样品的萃取时间约为 10 分钟。气体取样后,将萃取针连接到气密注射器上,收集 0.5 毫升纯净的 N2 气体(解吸气体)。然后将萃取针插入加热的气相色谱进样口。然后对萃取出的残留溶剂进行热解吸,并使用气相色谱仪-火焰离子化检测器进行测定。虽然拟议方法对五种 1 类化合物显示出足够的灵敏度,但四氯化碳的检测器响应非常低。此外,这项研究还清楚地表明,不同粉末状药物制剂的动态萃取对残留溶剂的净化效率是不同的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Analytical Sciences
Analytical Sciences 化学-分析化学
CiteScore
2.90
自引率
18.80%
发文量
232
审稿时长
1 months
期刊介绍: Analytical Sciences is an international journal published monthly by The Japan Society for Analytical Chemistry. The journal publishes papers on all aspects of the theory and practice of analytical sciences, including fundamental and applied, inorganic and organic, wet chemical and instrumental methods. This publication is supported in part by the Grant-in-Aid for Publication of Scientific Research Result of the Japanese Ministry of Education, Culture, Sports, Science and Technology.
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