Content Determination of Bifonazole Gel from Different Manufacturers by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the quality of Bifonazole Gel from different manufacturers. METHODS:HPLC was per-formed on the column of Diamonsil C18 with mobile phase of methanol- water- tetrahydrofuran(75∶24∶1,V/V/V)at a flow rate of 1.0 ml/min,detection wavelength was 254 nm,column temperature was 23 ℃,and the injection volume was 10 μl. RESULTS:The linear range of bifonazole was 50-600 μg/ml (r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 97.71%-101.68%(RSD=1.16%,n=9). The contents of Bifonazole gel samples from 3 manufacturers were more than 10 mg/g,with little difference. CONCLUSIONS:The method is simple and accurate with good separation and re-producibility,and suitable for the content determination of Bifonazole gel. The investigated contents of products from different man-ufactures conform to relevant standards.