摘要
目的:建立用高效波相色谱法(HPLC)法测定氟康唑注射液的含量及有关物质的方法。方法:用十八烷基硅烷键合硅胶为填充剂,pH7.0的磷酸盐缓冲液-甲醇(55:45)为流动相,检测波长为260nm。结果:氟康唑注射液在浓度60～140mg·L^(-1)范围内,溶液的浓度与峰面积呈良好的线性关系。精密度试验RSD为0.35％(n=5),最小检出量为10ng,检出限度为0.05％。氟康唑注射液含量测定的平均回收率为99.7％,RSD为0.53％(r=5)。结论:本方法简单,快速,准确,可用于氟康唑注射液的含量测定和有关物质的检查。
OBJECTIVE To establish a method for determining the content and related substance of fluconazole injection by HPLC. METHODS The C18 column was used and the mobile phase was consisted of pH 7.0 phosphate-methanol(55:45). The detection wavelength was at 260 nm. RESULTS A good linearity was obtained in the concentration range of 60~ 140 mg.L-1 ,and the average recovery of fluconazole was 99.7% , RSD = 0.53%(n=5). CONCLUSIONS This method is simple, rapid, accurate and can be used to determine fluconazole and its related substance.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2003年第5期268-270,共3页
Chinese Journal of Hospital Pharmacy
关键词
高效液相色谱法
测定
氟康唑注射液
含量
HPLC
fluconazole
related substance
injection
contents determining
