A new fluorescence-based method for rapid and specific quantification of rotigotine in chitosan nanoparticles

A new, simple, rapid and sensitive fluorescence-based method has been developed and validated for the estimation of rotigotine (RTG) in bulk and nanoformulations. RTG is a dopamine agonist approved by both the United States Food and Drug Administration and the European Medicines Agency for the treat-ment of Parkinson's disease and restless leg syndrome. To date, no fluorescence-based analytical method has been reported for the estimation of RTG in any pharmaceutical dosage forms. The developed method is validated as per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines. A solution of the pure drug in phosphate buffer pH 6.4 exhib-ited strong fluorescence emission (kem) at a wavelength of 298 nm when excited (kex) at a wavelength of 277 nm. The developed method demonstrated good linearity over a range of 250-2500 ng/mL. Limit of detection and limit of quantitation values were found to be 36.25 ng/mL and 109.85 ng/mL respectively. The developed method was found to be accurate, precise, specific and robust. The validated method was successfully applied for the estimation of entrapment efficiency and drug loading of in-house intranasal RTG-loaded chitosan nanoparticles. (c) 2021 Elsevier B.V. All rights reserved.

Automated summary

A new fluorescence-based method for estimating rotigotine in bulk and nanoformulations has been developed and validated. The method demonstrates good linearity and accuracy, and is specific and robust for use in pharmaceutical dosage forms.