Determination of the Related Substances in Sertaconazole Nitrate Vaginal Tablet by HPLC / 中国药房

ABSTRACT

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-SIONSThe method is accurate and reliable with high sensitivity and strong specificity,and can be used for the related substances in Sertaconazole nitrate vaginal tablet.