RESUMO
A Spectrophotometric method for the determination of Gemifloxacin mesylate [GFX] is developed and validated according to ICH guidelines. GFX is a fluoroquinolone that is used in the treatment of pneumonia. The analysis of the pure drug was carried out at its 'k[max] 270 nm. The method was linear from 0.5-5microg/mL, r[2] 0.999 and equation is 0.102-0.000. The % RSD for inter-day [0.969%] and intra-day [0.714%] assuring a good precision and accuracy was close to 100%. Limit of detection and Limit of quantification were 0.197 and 0.599|ug/mL, respectively
The validation results and statistical data demonstrate that the method is accurate, sensitive, cost effective and reproducible and has an importance in quality assurance of GFX analysis. The developed method was proved suitable for analysis of GFX in the pure and tablet dosage forms without interference of excepients