Abstract

The purpose of this study was to provide a quantification method with rapid, sensitive, reproducible and cost effective for gentamicin in the form of ninhydrin-gentamicin complex. The utilization of spectrophotometric module to validate the method development for gentamicin loaded microparticles was intended to provide alternative quantification method without compromising the sensitivity of the developed method. The wavelength was determined to be at 418 nm with 421 nm and 415 nm were selected for the robustness of the method selectivity. The linearity of 6 known concentrations of ninhydrin-gentamicin complex was obtained with the R2 of 0.9998. The interday and intraday precisions were determined with the acceptance %RSD values of less than 2%. In fact, the highest %RSD value was 1.09% which suggested the method to be acceptably precise. The LOD and LOQ values were recorded to be at 0.016 mg/mL and 0.196 mg/mL respectively. The % recovery of 4 known concentrations indicated the accuracy of the method was high with the recovery range between 98.66% to 101.8%. The parameters analyzed in this study were in accordance with ICH Q2 (R1) guidelines. This quantification method developed by using spectrophotometric module was a promising approach to provide a rapid and cost effective in evaluating gentamicin concentration for in-vitro applications.

Key words: Spectrophotometry; Gentamicin; Ninhydrin; Microparticles; Method Development.