Economic chromatographic methods for simultaneous quantitation of some fluoroquinolones and corticosteroids present in different binary ophthalmic formulations

Abstract

In this context, a simple RP-HPLC method is presented for the concurrent determination of Ofloxacin (OFX), Gatifloxacin (GFN), Dexamethasone sodium phosphate (DSP), and Prednisolone acetate (PA). The method has the strengths of being green, rapid, accurate, reproducible and cost-effective. The chromatographic separation utilized sodium phosphate as buffer with pH 3.0 ± 0.1 and acetonitrile 70:30 v/v for 3 min then reversing the ratio for the rest of the run with flow rate 1 mL min⁻¹, Xselect^® C₁₈ column and detection at 243 nm for DSP and PA, and 290 nm for OFX and GFN. Another chromatographic method was designed for the assay of the same drugs, namely TLC-Densitometric method. This method has the advance of being eco-friendly, simple and robust. The separation was obtained using mobile phase mixture of butanol/acetic acid/water (60:20:20 v/v/v) and normal phase silica gel plates as the stationary phase with simultaneous detection at 243 nm. The suggested methods can be adopted for the analysis of the four drugs in different binary combinations of eye drops saving money and solvents, and chemicals. They were validated with the guidance of ICH guidelines, with acceptable accuracy, precision, and selectivity.

Graphical Abstract

Keywords:

• Chromatography
• dexamethasone
• gatifloxacin
• green
• ofloxacin
• prednisolone

Authors’ contribution

All authors have participated in (a) conception and design, or analysis and interpretation of the data; (b) drafting the article or revising it critically for important intellectual content; and (c) approval of the final version.

Disclosure statement

This manuscript has not been submitted to, nor is under review at, another journal or other publishing venue. The authors have no affiliation with any organization with a direct or indirect financial interest in the subject matter discussed in the manuscript.