Determination of Related Substances of Bifonazole Raw Material by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the determination of related substances in bifonazole raw material. METH-ODSHPLC method was performed on the column of Kromasil C18 with mobile phase of methanol-0.02 mol/L phosphoric acid(ad-justed pH to 7.5 with triethylamine)(7030,V/V)at a flow rate of 1.0 ml/min,detection wavelength was 258 nm,volume injection was 20 μl,and the column temperature was 40 ℃. RESULTS:The linear range was 0.05-0.25 μg/ml for bifonazole(r=0.9996), 0.05-0.25 μg/ml for impurity A(bifonol)(r=0.9997)and 0.05-0.25 μg/ml for impurity B(4-C isomer)(r=0.9995);the detec-tion limits were 8.2 ng/ml,7.5 ng/ml and 8.4 ng/ml,and the quantification limits were 27.1 ng/ml,24.7 ng/ml and 27.8 ng/ml,re-spectively;RSDs of precision and reproducibility tests were lower than 1%;recovery of impurity B was 95.13%-101.29%(RSD=1.89%,n=9);both impurity A and impurity B were were detected in the 3 batches of samples. CONCLUSIONS:The method is accurate,sensitive and reproducible,and can be used for the determination of the related substances in bifonazole raw material.