Two Eco-Friendly Chromatographic Methods Evaluated by GAPI for Simultaneous Determination of the Fluoroquinolones Moxifloxacin, Levofloxacin, and Gemifloxacin in Their Pharmaceutical Products

In this paper, novel green HPLC and HPTLC chromatographic methods were developed for the concurrent determination of moxifloxacin, levofloxacin, and gemifloxacin in bulk and pharmaceutical products. The green HPLC method was used on Thermo C18 (4.6 x 250 mm, 5 mu m). By mixing ethanol and 20 mM sodium dihydrogen phosphate dihydrate (pH 5) in a ratio of 25:75, v/v, the mobile phase was created using isocratic elution. The flow rate was 1 mLmin(-1). The studied antibiotics were separated well within 9.5 min. The green HPTLC method was used on coated HPTLC aluminum sheets with Silica gel 60 F254 using a mobile phase mixture of water: acetone: ammonia (8:1:1, v/v/v). Compact and well-resolved peaks were obtained under chamber-saturation circumstances for the standard fluoroquinolone antibiotics. Both methods were optimized individually, validated by ICH, and assessed using the Green analytical procedure index (GAPI). The methods were applied to pharmaceutical products and compared with the published methods for the determination of each of these antibiotics individually, using Student's t-test. They can be used by quality-control laboratories in pharmaceutical factories as sensitive eco-friendly methods for the analysis of these drugs and for the detection of cross-contamination during manufacturing processes.

Automated summary

Novel green HPLC and HPTLC chromatographic methods were developed for the concurrent determination of moxifloxacin, levofloxacin, and gemifloxacin. Both methods were optimized, validated, and assessed using the Green analytical procedure index (GAPI). The results showed that these methods are suitable for pharmaceutical analysis and detection of cross-contamination during manufacturing processes.