Detection of Impurities in Bulk Drug and Capsule of Fluconazole

Abstract

Objectives: The purpose of this study was to identify the impurities and their amounts in the fluconazole bulk drug and capsule FLUNACTM (150 mg). Method: HPLC with diode array detector was used to carry out the study. The composition of mobile phase was acetonitrile: water (85:15 %) with flow rate of 0.7 mL/min and detected at 260 ± 1 nm. Results: Two impurities (one is known impurity A and other unknown impurity) were detected in the bulk drug and also in capsule FLUNAC (150mg). The total amount of impurities in fluconazole bulk drug and capsule were 0.368% and 0.392% respectively. Conclusion: The total amount of impurities was less than 1% which is acceptable.