Highly Sensitive Spectrofluorimetric Method for Determination of Certain Aminoglycosides in Pharmaceutical Formulations and Human Plasma

• Published in: AAPS PharmSciTech Vol. 14; no. 2; pp. 828 - 837
• Main Authors: Omar, Mahmoud A., Nagy, Dalia M., Hammad, Mohamed A., Aly, Alshymaa A.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.06.2013
• Subjects: Aminoglycosides - administration & dosage; Aminoglycosides - analysis; Aminoglycosides - blood; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - analysis; Anti-Bacterial Agents - blood; Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Buffers; Calibration; Chemistry, Pharmaceutical; Chloroform - chemistry; Humans; Hydrogen-Ion Concentration; Injections, Intramuscular; Linear Models; Ointments; Pharmacology/Toxicology; Pharmacy; Phenazines - chemistry; Reference Standards; Reproducibility of Results; Review; Review Article; Solvents - chemistry; Spectrometry, Fluorescence - standards; Tablets; Technology, Pharmaceutical - methods; Technology, Pharmaceutical - standards; spectrofluorimetry; aminoglycosides; safranin; dosage forms; human plasma
• ISSN: 1530-9932; 1530-9932
• DOI: 10.1208/s12249-013-9969-6

A simple, reliable, highly sensitive and selective spectrofluorimetric method has been developed for determination of certain aminoglycosides namely amikacin sulfate, tobramycin, neomycin sulfate, gentamicin sulfate, kanamycin sulfate and streptomycin sulfate. The method is based on the formation of a charge transfer complexes between these drugs and safranin in buffer solution of pH 8. The formed complexes were quantitatively extracted with chloroform under the optimized experimental conditions. These complexes showed an excitation maxima at 519–524 nm and emission maxima at 545–570 nm. The calibration plots were constructed over the range of 4–60 pg mL −1 for amikacin, 4–50 pg mL −1 for gentamicin, neomycin and kanamycin, 4–40 pg mL −1 for streptomycin and 5–50 pg mL −1 for tobramycin. The proposed method was successfully applied to the analysis of the cited drugs in dosage forms. The proposed method was validated according to ICH and USP guidelines with respect to specificity, linearity, accuracy, precision and robustness. The high sensitivity of the proposed method allowed determination of amikacin and gentamicin in spiked and real human plasma.