HPLC法测定癸酸氟哌啶醇有关物质

发布时间：2018-06-14 00:39

  本文选题：癸酸氟哌啶醇 + 有关物质　； 参考：《中国新药杂志》2017年21期

【摘要】：目的:建立高效液相色谱法分离测定癸酸氟哌啶醇及其有关物质。方法:采用Hypersil GOLD C18色谱柱(150 mm×4.6 mm,3μm),柱温35℃,流动相为17 g·L-1四丁基硫酸氢铵溶液-乙腈,进行梯度洗脱,流速1.5 m L·min~(-1),检测波长230 nm。结果:癸酸氟哌啶醇与各已知杂质及强制破坏产生的降解产物均分离良好;杂质A,B,C,D,E,F,G,H,I,G,K和L在各自的线性范围内质量浓度与峰面积呈良好的线性关系(r0.995 0,n=5),且校正因子均在0.9~1.1的范围内;上述杂质的平均回收率(n=9)分别为108.1%,104.0%,108.3%,101.2%,108.1%,98.2%,102.2%,93.5%,105.3%,96.7%,113.3%和100.3%,RSD分别为2.82%,3.22%,2.30%,5.28%,1.30%,4.54%,7.26%,8.01%,2.76%,2.98%,1.87%和6.71%;精密度试验RSD分别为0.40%,0.55%,0.44%,0.71%,0.60%,0.57%,0.48%,0.47%,0.50%,0.47%,0.57%和0.62%。结论:本方法灵敏快速、准确、可靠,专属性强,可用于癸酸氟哌啶醇的杂质检查。
[Abstract]:Objective: to establish a HPLC method for the separation and determination of haloperidol sebacate and its related substances. Methods: Hypersil gold C18 column was used, column temperature was 35 鈩，

本文编号：2016242