HPLC法测定硝酸舍他康唑阴道片的有关物质  

Determination of the Related Substances in Sertaconazole Nitrate Vaginal Tablet by HPLC

作　　者：周祥富 王康俊[2] 

机构地区：[1]三亚市人民医院药学部,海南三亚572000 [2]海南省药品检验所,海口570216

出　　处：《中国药房》2016年第15期2144-2146,共3页China Pharmacy

基　　金：海南省自然科学基金资助项目(No.813273)

摘　　要：目的：建立测定硝酸舍他康唑阴道片有关物质的方法。方法：采用高效液相色谱法。色谱柱为Hypersil BDS C18（150mm×4.6 mm,5μm）,流动相为0.5%醋酸铵溶液-乙腈-甲醇（15∶42.5∶42.5,V/V/V）,流速为1.0 ml/min,检测波长为220 nm,柱温为25℃,进样量为20μl。结果：硝酸舍他康唑阴道片中有关物质能达到较好的分离;硝酸舍他康唑检测质量浓度线性范围为12.24-28.56μg/ml（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈1%;加样回收率为99.38%-99.80%,RSD=0.14%（n=9）。结论：该方法准确、可靠、灵敏度高、专属性强,可用于硝酸舍他康唑阴道片的有关物质测定。OBJECTIVE：To establish a method for determination of the related substances in Sertaconazole nitrate vaginal tablet. METHODS： HPLC was performed on the column of Hypersil BDS C18（150 mm×4.6 mm,5 μm）with mobile phase of 0.5%Ammomium acetate solution-acetonitrile-methanol（15 ∶ 42.5 ∶ 42.5,V/V/V） at a flow rate of 1.0 ml/min,detection wavelength was220 nm,column temperature was 25 ℃,and the injection volume was 20 μl. RESULTS： The related substances in Sertaconazole nitrate vaginal tablet can be well separated;the liner range of sertaconazole nitrate was 12.24-28.56 μ g/ml（r=0.999 9）;RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 99.38%-99.80%（RSD=0.14%,n=9）. CONCLUSIONS：The method is accurate and reliable with high sensitivity and strong specificity,and can be used for the related substances in Sertaconazole nitrate vaginal tablet.

关 键 词：硝酸舍他康唑阴道片 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]