DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR FLUCONAZOLE AND IVERMECTIN IN TABLET FORMULATION BY USING RP-HPLC

Authors

  • Dubey P.K
  • Harod S. Sanjay

Keywords:

Analytical Method Development, Validation, Tablet Dosage Form

Abstract

A simple, efficient and reproducible RP-HPLC method for the simultaneous determination of Fluconazole and Ivermectin in bulk and tablet formulation has been developed and validated. The separation was carried out using Insertil C18 column (250 mm x 4.6 mm, 5 $ \mu $) using Acetonitrile:Methanol:Water (75:15:10 v/v/v) as mobile phase. The flow rate was 1.5 ml/min and detection was carried out 254 nm. The retention time of Fluconazole and Ivermectin were 2.313 and 9.617 respectively. The linear was established in the range of 50-150 $ \mu $g/ml and 52-156 µg/ml for Fluconazole and Ivermectin respectively. Percentage recoveries for Fluconazole and Ivermectin were found to be 99.830±1.079 and 100.814±1.99 respectively. All the analytical validation parameters were determined and found in the limit as per ICH Guidelines which indicate the validity of the method. The developed method is also found to be precise and robust for the simultaneous determination of Fluconazole and Ivermectin in tablet formulation.

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Published

11-08-2012