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高效液相色谱法测定氟康唑注射液的含量及有关物质
引用本文:王娅娟,逄书明,石艳萍.高效液相色谱法测定氟康唑注射液的含量及有关物质[J].中国医院药学杂志,2003,23(5):268-270.
作者姓名:王娅娟  逄书明  石艳萍
作者单位:1. 山东教育学院化学系,山东,济南,250013
2. 山东省医药工业研究所,山东,济南,250100
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。

关 键 词:高效液相色谱法  测定  氟康唑注射液  含量
文章编号:1001-5213(2003)05-0268-03
修稿时间:2002年7月13日

Dtermination of fluconazole injection and its related substance by HPLC
WANG Ya-Juan,PANG Shu-Ming,SHI Yan-Ping.Dtermination of fluconazole injection and its related substance by HPLC[J].Chinese Journal of Hospital Pharmacy,2003,23(5):268-270.
Authors:WANG Ya-Juan  PANG Shu-Ming  SHI Yan-Ping
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.
Keywords:HPLC  fluconazole  related substance  injection  contents determining
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