Determination of Gentamicin Released from Orthopedic Carrier System by a Novel HPLC Method

Abstract

A new, fast high-performance liquid chromatograpic-UV method has been developed and validated for quantitative analysis of gentamicin carrier samples drawn in drug release studies. The samples of the calibration curve were prepared in physiological salt solution, which were applied as dissolution medium for the drugs. The calibration curve is in the range of 1-100 µg/mL. The mobile phase consisted of methanol-water-acetate buffer (0.02 M ammonium acetate solution, adjusted with cc. ammonia to pH = 9), a reverse phase, Zorbax Rx-C-18 2.1 × 150 mm, 5 µm column has been used. Validation procedure of this newly developed method is carried out. Linearity, specificity, intra- and inter-day precision and accuracy, robustness, limits of detection, and quantitation are investigated.