Autologous Bone Marrow Transplantation.

Abstract

Background: Control of the active pharmaceutical ingredient plays a crucial role in ensuring the required efficacy. Therefore, a new accurate, reproducible, and green RP-HPLC method was developed for determining Gatifloxacin in bulk and eye drops.

Methods: The chromatographic separation was carried out using (isopropanol: phosphate buffer, pH=3±0.1 ) (35:65) v/v as mobile phase, the column used was C8 5μ (4.6*150mm) Inert Sustain GL Sciences column at temperature 〖40〗^° C, the flow rate was 0.8 mL/min, the UV detector was set at 280 nm and the injection volume was 10 μL. The greenness of the method was evaluated using Eco-scale tool.

Results: ICH guidelines were applied to prove the validity of the developed method. The linearity was achieved in the range 10-120 mg/l for Gatifloxacin with an excellent correlation coefficient R2=1. The LOD and LOQ were found to be 0.026 and 0.08 mg/l respectively. The precision was studied as intra- and inter-day with relative standard deviations not more than 2%, and the accuracy by mean recoveries ranged from 99.36 to 102.25%. The developed method was successfully applied for to determine Gatifloxacin in marketed eye drops. Eventually, the Eco-scale tool revealed a high degree of greenness by using relatively more eco-friendly solvents.

Conclusion: A new, sensitive, green, and accurate reversed-phase liquid chromatographic method is developed and validated to determine gatifloxacin in bulk and ophthalmic formulations using a UV detector under isocratic conditions.

Keywords: RP- HPLC, Gatifloxacin, Eye Drops,  Method Validation, Greenness Assessment.