摘要
目的:建立以气相色谱法测定白消安片中白消安含量的方法。方法:用20%碘化钠丙酮溶液作为衍生化试剂,在50℃水浴加热回流90 min,生成1,4二碘代丁烷,以1,5二碘代戊烷作为内标,以1.5%OV-17,Chromosorblow(AW—DMCS)为气相色谱柱(φ3 mm×2 m 80×100目),柱温110℃,FID检测器,载气为氮气,流速为50 mL·min^(-1),测定白消安的含量。结果:白消安在25-200μg·mL^(-1)范围间呈良好线性关系,平均加样回收率为:100.5% RSD为1.1%.结论:本方法方便,准确,重现性好,可作为本制剂的质量控制方法。
Objective: To establish a GC method for determining the content of busulfan in busulfan tablets. Methods: Under refiux for 90 minites by water bath at 50℃, diiodobutane have been produced using 20% sodium iodide in acetone solution as derivative agent. Using diiodopentanc as inter standard, the contents of busulfan were assayed by a 1. 5% OV-17,Chromosorlow(AW-DMCS)column with column temperature at 110℃ and detector(FID), using nitrogen as the carrier gas. The flow rate was 50 mL·min^(-1). Results;The standard curve of busulfan was linear over the range of 25-200 μg·mL^(-1). The average recovery of add sample was 100. 5%,and RSD was 1. 1 %. Conclusions; This method is simple, accurate and reproducible. It can be reliable for the quality control of busulfan tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第3期292-293,共2页
Chinese Journal of Pharmaceutical Analysis
