Micellar Liquid Chromatographic Determination of Idrocilamide in Dosage Form and Biological Fluids: Application to Stability Study

Abstract

A simple, stability-indicating, reversed phase high perfomance liquid chromatographic method was developed and validated for the determination of idrocilamide in the presence of its degradation products .The separation was conducted using A Hibar C18 (150 × 4.6 mm i.d ) stainless steel column at ambient temperature with UV detection at 277 nm . Micellar mobile phase consisted of 0.1 M sodium dodecyl sulphate, 10% n-propanol, 0.3 % triethylamine in 0.02 M phosphoric acid (pH 6) was used and pumped at a flow rate of 1 mL/min .The calibration curve was rectilinear over the concentration range of 1-10 μg/mL with a detection limit of 0.1 μg /mL and quantification limit of 0.3 μg/mL .The proposed method was successfully applied to the analysis of idrocilamide in commercial cream with mean % recovery of 100.74 ± 0.93. The method was extended to the in-vitro determination of idrocilamide in spiked human plasma and urine samples with mean % recoveries of 99.93 ± 0.31 and 100.1 ± 0.26 respectively Moreover, the method was utilized to investigate the kinetics of both acid and alkaline induced degradation of the drug . The apparent first –order rate constant, half life time and activation energies of the degradation reactions were calculated