Frink Lillian A, Armstrong Daniel W
Department of Chemistry and Biochemistry, University of Texas at Arlington, Arlington, Texas 76019.
Department of Chemistry and Biochemistry, University of Texas at Arlington, Arlington, Texas 76019.
J Pharm Sci. 2016 Aug;105(8):2288-92. doi: 10.1016/j.xphs.2016.05.014. Epub 2016 Jun 28.
A rapid, accurate, and precise headspace gas chromatographic (HSGC) analytical method was developed for the detection and quantification of water in drug products. The analysis is able to be performed in 10 min and automated. The HSGC method used an ionic liquid (IL) based open tubular capillary gas chromatographic column to increase the ruggedness of this method and provide improved peak shapes for water. Due to the ionic liquids low vapor pressure, unique physiochemical properties, and high thermal stability, they also make idea solvents for HSGC. Unlike Karl Fischer titration methods, this HSGC method is not affected by side reactions. The developed method was shown to be broadly applicable. The water content in 12 different samples was found to range from 1%-7% water. The use of HSGC was highly sensitive and only required 10 mg of sample. In addition, it was found to have greater precision and accuracy than Karl Fischer titration and greater precision and speed than loss on drying.
开发了一种快速、准确且精密的顶空气相色谱（HSGC）分析方法，用于检测和定量药品中的水分。该分析可在10分钟内完成且能自动化操作。HSGC方法使用基于离子液体（IL）的开管毛细管气相色谱柱，以提高该方法的耐用性，并为水提供更好的峰形。由于离子液体的低蒸气压、独特的物理化学性质和高热稳定性，它们也是HSGC的理想溶剂。与卡尔费休滴定法不同，该HSGC方法不受副反应影响。所开发的方法具有广泛的适用性。在12个不同样品中发现水含量在1%至7%之间。HSGC的使用高度灵敏，仅需10毫克样品。此外，发现它比卡尔费休滴定法具有更高的精密度和准确度，比干燥失重法具有更高的精密度和速度。
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