Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Development and validation of a chromatographic method for quantification of rasagiline in human plasma

Rabiea Bilal¹ , Muhammad Usman², Abdul Muqeet Khan³, Waqas Latif⁴, Naseem Saud Ahmad⁵, Sualeha Riffat²

¹Department of Pharmacology, CMH Lahore Medical and Dental College, Abdul Rehman Road, Lahore Cantt; ²Institute of Pharmaceutical Sciences; ³Quality Operations Laboratory, University of Veterinary and Animal Sciences; ⁴Quality Enhancement Cell, University of Health Sciences; ⁵Department of Pharmacology, Sharif Medical and Dental College, Lahore, Pakistan.

For correspondence:- Rabiea Bilal Email: docrabiea@gmail.com Tel:+92301848757

Accepted: 24 October 2018 Published: 30 November 2018

Citation: Bilal R, Usman M, Khan AM, Latif W, Ahmad NS, Riffat S. Development and validation of a chromatographic method for quantification of rasagiline in human plasma. Trop J Pharm Res 2018; 17(11):2243-2248 doi: 10.4314/tjpr.v17i11.19

© 2018 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To develop a sensitive, reliable and cost-effective bioanalytical method for the pharmacokinetic analysis of rasagiline in human plasma.

Method: Rasagiline was extracted by liquid-liquid extraction method and analyzed by reversed-phase high performance liquid chromatography (HPLC) using a mixture of ammonium acetate (pH 5.8) and acetonitrile (55:45, v/v) as mobile phase at a flow rate of 1 mL/min. The separation was performed on a Lichrosphere reverse-phase (RP) C18 column (250 x 4.6 mm, 5 μm particle size) at ambient temperature and rasagiline was detected at a wavelength of 265 nm by ultra-violet UV detection. The method was validated according to European Medicine Agency (EMA) guidelines.

Results: The developed method was linear over a concentration range of 0.5 - 20 µg/ml with r2 ≥ 0.999 in human plasma. Run time was 10 min with rasagiline peak appearing at 7 min with no interference. Relative recovery and relative standard deviation (RSD) for accuracy and precision were within the acceptable limits prescribed in EMA guidelines. Rasagiline remained stable in human plasma for 24 h at room temperature, after three freeze and thaw cycles and also for 3 months at -20 °C.

Conclusion: A simple and reliable method has been successfully developed and validated for the determination of rasagiline concentration in human plasma.

Keywords: Rasagiline, Pharmacokinetics, Validation, Parkinson's disease