节点文献
高效液相色谱法测定氟康唑注射液的含量及有关物质
Dtermination of fluconazole injection and its related substance by HPLC
【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。
【Abstract】 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.
【Key words】 HPLC; fluconazole; related substance; injection; contents determining;
- 【文献出处】 中国医院药学杂志 ,Chinese Journal of Hospital Pharmacy , 编辑部邮箱 ,2003年05期
- 【分类号】R927.2
- 【被引频次】8
- 【下载频次】163