Eco-friendly HPLC Method for the determination of Ranolazine using Cyclodextrin as a green additive to mobile phase

Abstract

Background: 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. Methods: 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. Results: 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 tR 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. Conclusion: 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.