摘要
目的 :建立测定司坦夫定及其有关物质含量的高效液相色谱法。方法 :分析柱 :HypersilC18(4 6mm×150mm ,5μm) ;流动相 :甲醇 -水 (13∶87,V/V) ;检测波长 :264nm ;流速 :1ml/min ;柱温 :20℃。结果 :司坦夫定在0 025~0 3mg/ml范围内呈现良好的线性关系 (r=0 9999 ,n=6) ,平均回收率为99 26 % (RSD=0 76 % )。3批司坦夫定原料的百分含量依次为99 48 %、99 55 %和99 32 % ;3批司坦夫定自制胶囊和进口胶囊的百分标示量依次为97 21 %、101 54 %、98 92 %和100 57 %、97 86 %、102 33 %。结论 :本方法具有简便、准确、灵敏且重现性好的特点 ,可用于司坦夫定原料及其制剂的含量测定。
OBJECTIVE:To establish a HPLC method for the determination of stavudine and related substances METHODS:The Hypersil C18(4 6mm×150mm,5μm)was used as analysis column The mobile phase was methanol-water(13∶87,V/V) Detection wavelength was 264nm The flow rate was 1ml/min The column temperature was 20℃ RESULTS:The calibration curves was linear in the concentration range of 0 025~0 3mg/ml(r=0 9 999,n=6) The average recovery was 99 26%(RSD=0 76%) The contents of stavudine in 3 batches of semifinished materials and stavudine capsules(imported and domestic)were 99 48%,99 55%,99 32%(materials);97 21%,101 54%,98 92%(imported stavudine capsule);100 57%,97 86%,102 33%(domestic stavudine capsule)respectively CONCLUSION:The method is simple,accurate,sensitive and repeatable and it is suitable for the determination of stavudine and its preparations
出处
《中国药房》
CAS
CSCD
2002年第7期428-429,共2页
China Pharmacy
关键词
司坦夫定
含量测定
高效液相色谱法
stavudine
related substance
content determination
HPLC