DEVELOPMENT AND VALIDATION OF A HPLC METHOD FOR DIRECT ESTIMATION OF CICLOPIROX OLAMINE IN EX VIVO TRANSUNGUAL PERMEATION STUDIES

Abstract

A new hPLc method was developed for direct estimation of ciclopirox olamine in ex vivo transungual permeation samples by suppressing the chelating property of ciclopirox using disodium EDTA in mobile phase and endcapped hPLc column to reduce silanophilic interaction with drug. chromatographic separation was achieved on hypersil® Phenyl BDS column (250mm × 4.6mm, 5µm) using disodium EDTA in water (0.96 in 1000): acetonitrile: acetic acid (60:40:0.1, V/V/V) as mobile phase at a flow rate of 1mL/min, and estimated at 305nm. The method was validated for specificity, accuracy, precision, linearity, LOD, and LOQ. Ciclopirox was specifically quantified at 7.491min in the presence of forced degradation products. Linearity was established between 1-10µg/mL with a correlation coefficient of 0.999. The LOD and LOQ were 0.5 and 1µg/mL, respectively, which proved the ability of developed method to analyze ciclopirox in low concentration samples. The method could be successfully applicable in analyzing ex vivo transungual permeation study samples of ciclopirox olamine.