Abstract
Doripenem monohydrate (DOR), is a recently FDA approved β- lactam antibiotic. DOR belongs to carbapenems class and it is used for the treatment of several diseases caused by different strains of bacteria. Herein, new highly sensitive, low casting, and selective spectrofluorimetric method was developed and validated for determination of DOR in real human plasma. The developed approach based on the reaction of 4-Chloro-7-nitrobenzofurazan (NBD-Cl) with secondary amine moiety in DOR using 0.1 M borate buffer at pH 8.5 producing fluorescent product measured at 535 nm (λex at 475 nm) after heating for 8 min at 70 °C. The calibration range was studied under optimum conditions and it was linear from 30 to 500 ng mL−1, with LOD 9.73 ng mL−1 and LOQ 24.05 ng mL−1. The investigated method was validated and bio-analytically validated using ICH and FDA recommendations. Moreover, the proposed method was successfully utilized to quantify DOR in a commercial formulation, human plasma and urine with high percentage of recovery in the range of 97.26% to 98.89% for plasma samples and within the range of 99.28% to 99.84% for urine samples. Further, the proposed method was successfully applied for extensive pharmacokinetic study in order to improve patient health.