ISSN : 2663-2187

Validated spectrophotometric methods for the determination of fluoroquinolone antibiotic: Gemifloxacin mesylate in pharmaceutical formulations using ceric (IV) ammonium sulfate

Main Article Content

Ragaa El Sheikh, Ayman A. Gouda*, Ahmed El Sayed, Moataz S. Mahmoud, Ahmed F. Abdel Allem, Nesma M. Jumaa, Noha E.M. Elsaify, Nehal S.A. Soliman, Asmaa El Sayed
» doi: 10.48047/AFJBS.6.2.2024.2383-2394

Abstract

Background: A validated, sensitive, precise, and dependable spectrophotometric technique has been developed to accurately detect the concentration of gemifloxacin mesylate (GMF) in pure and dosage forms. The methods utilise ceric(IV) ammonium sulfate (Ce(IV)) as an oxidising agent and 3 specific dyes: amaranth (AM), methylene blue (MB), and methyle orange (MO). The ways depend on the oxidation process of GMF using a plentiful quantity of ceric(IV) ammonium sulfate in acidic circumstances. The residual ceric(IV) ammonium sulfate is measured by subjecting it to a chemical reaction with preset amounts of dyes, AM, MB, and MO. The absorbance is measured at λmax of 520, 664 and 510 nm for AM, MB, and MO dye, respectively. The analytical technique was implemented and validated by thoroughly examining and optimizing various factors that could potentially disrupt the reaction. Significant linear relationships, characterized by correlation coefficients ranging from 0.9990 to 0.9997, were observed under optimal conditions. These associations remained consistent throughout concentration ranges of 1.0-10, 1.0-12, and 1.0-14 µg/ml. The limits of detection (LOD) of 0.30, 0.29, and 0.28 µg/ml for AM, MB, and MO methods, respectively. The calculated molar absorptivity values are 2.789 × 104, 2.390 × 104 and 1.7436 × 104 L.mol-1.cm-1 using AM, MB and MO methods, respectively. The accuracy and precision of the approaches' have been evaluated for measurements conducted within a single day as well as measurements conducted over multiple days. The methods were successfully applied to the assay of gemifloxacin mesylate in tablets and the results were statistically compared with those of the reference method by applying Student’s t-test and F-test. No significant interference was observed with the usual pill excipients.

Article Details