Determination of Residual Solvents from Pharmaceutical Formulations using a Needle-Type Extraction Device

2023 Fiscal Year Final Research Report

• Project/Area Number: 21K06491
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 47020:Pharmaceutical analytical chemistry and physicochemistry-related
• Research Institution: University of Yamanashi
• Principal Investigator: Ueta Ikuo 山梨大学, 大学院総合研究部, 准教授 (50598688)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: 残留溶媒 / 揮発性有機化合物 / ガスクロマトグラフィー

Outline of Final Research Achievements

This research developed a rapid screening method to determination residual solvents in a tablet formulation using a needle-type extraction device. The tablet formulation was pulverized, and the powdered sample was rapidly inserted into a pipette tip. A needle-type extraction device packed with Carbopack X and a carbon molecular sieve was inserted into the pipette tip, and 100 mL of the gas sample was collected.
In this research, two extraction methods; dynamic extraction and purge-and-trap method were investigated.

Free Research Field

分析化学

Academic Significance and Societal Importance of the Research Achievements

製剤中の残留溶媒分析は、製剤を接種する人々の健康を守る上で非常に重要であるが、長年にわたり、分析法の改善は行われてきておらず、公定法による分析では長時間の試料前処理操作が必要である。本研究では、従来法よりも極めて短時間かつ簡便に製剤中の残留溶媒を定量分析することが可能であり、本研究で得られた成果は日本国内のみならず、世界中で意義があると考える。