Determination of related substances in fluconazole bulk drug / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish an HPLC gradient elution method for the determination of related substances in fluconazole bulk drug. METHODS: The separation was achieved by using an ODS column with gradient elution of mobile phase composed of 0.01 mol · L-1 ammonium formate and acetonitrile. The flow rate was 0.5 mL · min-1. The UV detection wavelength was 261 nm, injection volume is 20 μL. RESULTS: Fluconazole and its related substances can be separated effectively by this method, linear relation of fluconazole and impurity B-D were good, the detection limit were 0.20, 0.0052, 0.0073, 0.13 μg · mL-1, seventeen batches sample from nine manufacturers were determined. The related substances in fluconazole bulk drug were effectively determined. CONCLUSION: The HPLC method is rapid and accurate which may be used for the inspection of related substances in fluconazole bulk drug. Copyright 2012 by the Chinese Pharmaceutical Association.