摘要
目的:建立以高效液相色谱法测定尼尔雌醇阴道用凝胶剂中尼尔雌醇含量的方法。方法:色谱柱为Hypersil ODS,流动相为甲醇-水(80:20),检测波长为221nm,流速为1.0mL.min-1,进样量为20μL。结果:尼尔雌醇检测浓度的线性范围为20.06～200.6μg.mL-1(r=0.9999),最低检出限及最低定量限分别为3.41、5.92μg.mL-1;平均回收率为100.8%,RSD=1.2%。结论:该方法操作简便,结果准确,可用于测定尼尔雌醇阴道用凝胶剂中尼尔雌醇的含量。
OBJECTIVE： To develop an HPLC Method for the determination of the content of nilestriol in nilestriol vaginal gel. METHODS： The chromatographic separation was carried out on column Hypersil ODS, the mobile phase consisted of methanol- water （80 ： 20）, the detection wavelength was 221 nm, the flow rate was 1.0 mL ~ rain-1 and the injection volume was 20 μL. RESULTS： The calibration curve was linear in the range of 20.06--200.6 μg.mL^-1 （r = 0.999 9）, the lowest detection limit was 3.41μg.mL^-1 and the lowest quantitative limit was 5.92μg.mL^ -1. The average recovery rate was 100.8% （RSD = 1.2% ）. CONCLUSION： The method is simple, accurate and applicable for the determination of the content of nilestroil in nilestroil vaginal gel.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第22期1735-1736,共2页
China Pharmacy
基金
深圳市科技计划项目(200803046)
