气相色谱法测定复方水合氯醛口服溶液中水合氯醛含量  

Determination of chloral hydrate content in compound chloral hydrate oral solution by GC

作　　者：杜建红[1] 钟元高[2] 何德云[1] 涂显勤 DU Jianhong;ZHONG Yuangao;HE Deyun;TU Xianqin(Institute for Drug and Instrument Control of Chengdu Military Region,Chengdu 610017,China;Bayi Orthopedics Hospital of Chengdu Military Region,Chengdu 610015,China)

机构地区：[1]成都军区联勤部药品仪器检验所,四川成都610017 [2]成都军区八一骨科医院,四川成都610015

出　　处：《贵州科学》2018年第6期42-45,共4页Guizhou Science

基　　金：军队医疗机构制剂标准提高科研专项课题面上项目(13ZJZ04-2)

摘　　要：目的:采用气相色谱建立复方水合氯醛口服溶液中水合氯醛的含量测定方法。方法:色谱柱:OV-624毛细管柱(30m×0. 53 mm,0. 5μm);柱温:100℃;氢离子火焰检测器(FID)温度:250℃;进样口温度:200℃;载气压力:氮气50 k Pa;氢气50 k Pa;空气流量:40 m L/min;进样量:1μL,进样方式:分流进样(1∶100);在此条件下进行方法学考察。结果:测定复方水合氯醛口服溶液中水合氯醛含量时,各方法学参数满足《中国药典》要求,水合氯醛在125μg/m L～2000μg/m L呈良好线性关系,精密度、重复性RSD分别为1. 96%、2. 97%;样品平均回收率为101. 04%,RSD为2. 03%。结论:气相色谱法适用于复方水合氯醛口服溶液中水合氯醛含量测定,且操作方便,简单易行。In this study,we established a method for the determination of chloral hydrate content in compound chloral hydrate oral solution by gas chromatography. OV-624 capillary column ( 30 m×0. 53 mm,0. 5 μm) was used,column temperature was 100℃,hydrogen ion flame detector ( FID) temperature was 250℃,inlet temperature was 200℃,gas pressure for nitrogen and hydrogen was 50 kPa,air flow was 40 mL /min,injection volume was 1 μL, and injection method was split injection ( 1 ∶100) . Under the above conditions,all the parameters met the requirements in Pharmacopoeia of China,chloral hydrate showed a good linear relationship within the range of 125 μg /mL to 2000 μg /mL,the precision and reproducibility RSD were 1. 96% and 2. 97% respectively,the average recovery of the sample was 101. 04%,and the RSD was 2. 03%. This method is simple and easy to operate,and is suitable for the determination of chloral hydrate content in compound chloral hydrate oral solution.

关 键 词：水合氯醛 气相色谱仪 含量 测定 

分 类 号：R917[医药卫生—药物分析学]