Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF FLUCONAZOLE AND IVERMECTIN IN TABLET DOSAGE FORM

Vishal U. Thodsare*, Sagar S. Kale, Ashpak S. Tamboli, Manoj S. Patil and Hasan I. Sharikhmulani

ABSTRACT

A simple, efficient and reproducible RP-HPLC method for the simultaneous determination of Fluconazole and Ivermectin in bulk has been developed and validated. The separation was carried out using Agilent Zorbax Bonus –RP (250×4.6mm, 5μ) using Methanol: 0.1% O-phosphoric acid (40:60, %v/v) as mobile phase the flow rate was 1 ml/ min and detection was carried out 220nm. The retention time of fluconazole and Ivermectin were 6.24 and 2.43 respectively. The linear was established in range of 120-180μg/ml and 4.8-7.2 μg/ml for Fluconazole and Ivermectin respectivrly. Percentage recoveries for Fluconazole and Ivermectin were found to be 99.66± 1.06 and 99.55±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.

Keywords: Fluconazole, Ivermectin, RP-HPLC, Analytical method Development and Validation.