Spectrophotometric Determination of Gentamicin Loaded PLGA Microparticles and Method Validation via Ninhydrin-Gentamicin Complex as a Rapid Quantification Approach.

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 undermining the sensitivity of the developed method. The microparticles fabrication process was proven to be suitable in encapsulating gentamicin by using poly(lactic-co-glycolic acid) PLGA without compromising the efficacy of the antibiotic itself. 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%. The highest %RSD value was 1.09% which suggested the method to be acceptably precise. The limit of detection (LOD) and limit of quantification (LOQ) values were recorded to be at 0.016 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% and 101.8%. The parameters analyzed in this study were in accordance with ICH Q2 (R1) guidelines. This quantification method was a promising approach to provide a rapid and cost effective in evaluating gentamicin concentration for in-vitro applications.

Method Development and Validation using UV Spectrophotometry for Nigella sativa Oil Microparticles Quantification.

Nigella sativa oil (NSO) has been exploited for medical purposes for many generations. The fabrication of microparticles containing NSO intended for sustained release was done to be used in treating osteomyelitis. Method in quantifying NSO using UV-spectroscopy was developed and validated. Linearity shown a good correlation coefficient with the values higher than 0.995, both for actual and different analysts. The LOD and LOQ values were recorded to be 2.89 μg/mL and 8.75 μg/mL respectively. In addition, the highest %RSD values for the intermediate and repeatability studies were 0.970% and 0.445% which suggested the method was precise. The percentage recovery for 4 known concentrations gave the range between 98.16% to 99.39%, indicating the high accuracy of the method. The parameters analyzed in this study were in accordance with ICH Q2 (R1) guidelines.