Eco-friendly HPLC method for the determination of ranolazine using cyclodextrin as a green additive to mobile phase

Minimizing the amount of organic solvents is one of the main goals of green analytical chemistry; Therefore, a rapid, simple, sensitive, and environmentally benign method for the determination of ranolazine in bulk and pharmaceuticaldosage form was developed.

The method based on using ethanol s a green solvent: (4mmol/L) sodium sulfobutyl ether-betacyclodextrin SBE-β-CD(pH in aqueous phase=4) (25:75)as a green mobile phase, C18 5μ (4.6*150mm) InertSustain GL Sciences column at room temperature 35°C, the flow rate was 1mL/min, the photo diode array detector was set at 210nm and injection volume was 20μL.

The developed method was validated according to International Conference on Harmonization guidelines and showed good linear relationship over the concentration range of 50-150mg/L with the correlation coefficient was obtained R² = 0.9999. The LOD and LOQ were found to be 1.91 and 5.81mg/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 between100.1-101%. The percentage recoveries of active pharmaceutical ingredient from dosage forms ranged between 99.67 - 100.2%. Addition of cyclodexetrine derivative to the mobile phase, decreases the retention time t_R of the compound by 64%, more over, it allowed the method to be greener by the ability to use high percentage of aqueous phase. GAPI and eco-scale were used to evaluate the greenness of the developed method.

The results showed that the developed eco-friendly method is suitable for the precise, accurate and rapid determination of Ranolazine in bulk and tablet dosage forms.