CAJ | 학술논문

建立了米氮平原料药中乙醇、二氯甲烷、三氯甲烷、四氢呋喃、N，N-二甲基甲酰胺等有机溶剂残留量毛细管气相色谱测定法。采用 HP-1毛细管柱（30 m×0.53 mm，3μm），以二甲基亚砜为溶剂，氮气为载气，FID检测器进行检测。结果表明：以上5种有机溶剂的浓度（μg·mL-1）分别在100.008～1000.080、12.124～121.244、1.202～12.016、14.433～144.328、17.659～176.592的范围内与峰面积的线性关系良好，检出限（μg·mL-1）分别为1.03、0.83、0.47、0.32、1.04；平均回收率分别为99.21％、98.72％、99.38％、99.03％、99.29％；精密度实验相对标准偏差（RSD）均小于1％。该方法灵敏、准确，可用于米氮平原料药中有机溶剂残留量的测定。
건립료미담평원료약중을순、이록갑완、삼록갑완、사경부남、N，N-이갑기갑선알등유궤용제잔류량모세관기상색보측정법。채용 HP-1모세관주（30 m×0.53 mm，3μm），이이갑기아풍위용제，담기위재기，FID검측기진행검측。결과표명：이상5충유궤용제적농도（μg·mL-1）분별재100.008～1000.080、12.124～121.244、1.202～12.016、14.433～144.328、17.659～176.592적범위내여봉면적적선성관계량호，검출한（μg·mL-1）분별위1.03、0.83、0.47、0.32、1.04；평균회수솔분별위99.21％、98.72％、99.38％、99.03％、99.29％；정밀도실험상대표준편차（RSD）균소우1％。해방법령민、준학，가용우미담평원료약중유궤용제잔류량적측정。
To determine content of residual organic solvents of ethanol,dichloromethane,chloroform,tetra-hydrofuran,N,N-dimethylformamide in mirtazapine,the capillary gas chromatography method was established. HP-1 capillary column (30 m×0.53 mm,3μm)was selected,the solvent was dimethyl sulfoxide,the carrier gas was nitrogen,and FID detector was used.The five kinds of organic solvents had good linear relationship at ran-ges of 100.008~1 000.080μg·mL-1,12.124~121.244μg·mL-1,1.202~12.016μg·mL-1,14.433~144.328μg·mL-1 ,17.659~176.592μg·mL-1 ,respectively;the minimum detectable quantity were 1.03μg· mL-1,0.83μg·mL-1,0.47μg·mL-1,0.32μg·mL-1,1.04μg·mL-1,respectively;the average recoveries were 99.21%,98.72%,99.38%,99.03%,99.29%,respectively;the precision RSD was all less than 1%.This method is sensitive and accurate,which can be used to determine the residual organic solvents in mirtazapine.