摘要
目的:建立同时测定氯喹那多-普罗雌烯阴道片中氯喹那多和普罗雌烯含量的方法。方法:采用华谱Tnature C 8色谱柱(4.6 mm×250 mm,5μm)以甲醇-0.02 mol·L^(-1)的磷酸二氢钾溶液-磷酸(85∶15∶0.3)为流动相,等度洗脱;检测波长分别为250 nm(氯喹那多)、220 nm(普罗雌烯);结果:氯喹那多在0.016~0.240 mg·mL^(-1),普罗雌烯在0.04~0.60 mg·mL^(-1)范围内有良好的线性关系(相关系数均为0.999),平均回收率氯喹那多为100.2%,普罗雌烯为99.8%。结论:本方法同时测定氯喹那多-普罗雌烯阴道片中2组分的含量,快捷、简便、准确、可用于该制剂的含量测定。
Objective:To establish an HPLC method for simultaneous determination of chlorquinaldol and promestriene in chlorquinaldol-prostrorene vaginal tablets.Methods:The test was performed in Tnature C 8 column(4.6 mm×250 mm,5μm)under the isocratic elution of methanol-0.02 mol·L^(-1) potassium dihydrogen phosphate solution-phosphoric acid(85∶15∶0.3)as the mobile phase.The detection wavelengths were 250 nm for chlorquinadol and 220 nm for Promestriene respectively.Results:The calibration curves showed a good linearity within the range of 0.016-0.240 mg·mL^(-1)(r=0.999)for chlorquinaldol and 0.04-0.60 mg·mL^(-1)(r=0.999)for promestriene.The average recoveries of chlorquinaldol and promestriene were100.2%and 99.8%respectively.Conclusion:The established method has the good precision and accuracy and can be used for simultaneous determination of two components in chlorquinaldol prostrorene vaginal tablets.
作者
张书彬
郑莎
易斌
韩雅慧
杨卓理
苏小楠
ZHANG Shubin;ZHENG Sha;YI Bin;HAN Yahui;YANG Zhuoli;SU Xiaonan(Beijing Slian Pharmaceutical Co.,Ltd.,Beijing 102600,China)
出处
《中国药品标准》
CAS
2021年第6期555-559,共5页
Drug Standards of China
