Gradient Multipeak Liquid Chromatographic Method for Determination of Ardacin in Bulk Chemical and Premix Formulations
Abstract A liquid chromatographic (LC) method was developed for the determination of ardacin in bulk chemical (78 to 100%, w/w anhydrous) and premix formulations (3.3 to 26.4%, w/w). The method is based on reversed-phase LC resolution of ardacin components and detection by UV absorbance at 220 nm. Ardacin has 10 components, and each component can be quantitated separately. Total ardacin is determined by summing the areas of the 10 component peaks. Calculations are performed using an external standard approach. The method is linear for ardacin at 50 to 150 μ/mL. The method accuracy for a typical bulk chemical is ± 1.5%, w/w (relative standard deviation [RSD], 1.6%), and recovery from a typical pilot scale premix is 99.9% (RSD, 3.4%). The method is useful for monitoring stability during storage.