HPLC法测定硝酸舍他康唑阴道片的有关物质

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（150 mm×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＝0.9999）；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 tab-let. 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 was 220 nm,column temperature was 25℃,and the injection volume was 20μl. RESULTS:The related substances in Sertaconazole ni-trate vaginal tablet can be well separated;the liner range of sertaconazole nitrate was 12.24-28.56 μg/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). CONCLU-SIONS: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.