气相色谱法同时测定利福平注射液中的1,2-丙二醇、二甘醇和环氧丙烷

发布时间：2017-12-28 03:11

本文关键词：气相色谱法同时测定利福平注射液中的1,2-丙二醇、二甘醇和环氧丙烷　出处：《中南药学》2016年12期 　论文类型：期刊论文

【摘要】：目的建立气相色谱法测定利福平注射液中有机溶剂的含量。方法采用气相色谱法,使用SUPEL COWAX固定相毛细管柱;以高纯氮气为载气;以FID为检测器。结果 1,2-丙二醇在31.83~1273.0μg·m L~(-1)与峰面积呈良好的线性关系,r=0.9999(n=6);二甘醇在1.5~60μg·m L~(-1)与峰面积呈良好的线性关系,r=0.9994(n=6);环氧丙烷在1.5~60μg·m L~(-1)与峰面积呈良好的线性关系,r=0.9993(n=6)。平均回收率均在96.1%~99.6%。结论该方法准确可靠,可用于利福平注射液中1,2-丙二醇、二甘醇和环氧丙烷的检测。
[Abstract]:Objective to establish a gas chromatographic method for the determination of the content of organic solvents in Rifampicin Injection. Methods gas chromatography was used, SUPEL COWAX fixed phase capillary column was used, high purity nitrogen was used as carrier gas, and FID was used as detector. Results 1,2- propylene glycol in 31.83~1273.0 ~ g ~ m L~ (-1) showed a good linear relationship with the peak area, r=0.9999 (n=6); two DEG in 1.5~60 g m L~ (-1) showed a good linear relationship with the peak area, r=0.9994 (n=6) 1.5~60 g; propylene oxide in M L~ (-1) showed a good linear relationship with the peak area, r=0.9993 (n=6). The average recovery rate is in 96.1%~99.6%. Conclusion the method is accurate and reliable, and can be used for the detection of 1,2- propanediol, two glycoll and propylene oxide in Rifampicin Injection.
【作者单位】：成都市食品药品检验研究院;
【分类号】：R927.2;O657.71
【正文快照】： 难溶药物的注射液制剂制备过程中需要用特殊的溶媒来使主药溶解。利福平是一种难溶药物,其注射液的生产过程中使用了1,2-丙二醇作为溶媒,而且量比较大,成品中所占比例较高。1,2-丙二醇在外用制剂、口服制剂、注射剂中广泛应用,在临床用药过程中发现,大剂量给药会产生乳酸中毒

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