Abstract

Selegiline HCl is an irreversible MAO-B inhibitor used to reduce symptoms in early-stage Parkinson’s disease. It is used as an adjunct to drugs such as L-DOPA.
The objective of the present work is to develop and validate a rapid, sensitive and straightforward LC method with Electrospray ionisation and triple quadrupole mass analyser for the quantification of selegiline hydrochloride in bulk and pharmaceutical formulation.
Chromatographic separation was achieved on a Zorbax C18 column (50mm x 4.6mm i.d, 5 particle size). The samples were eluted using 0.1% Formic acid in water: Methanol (40:60%v/v) at a flow rate of 0.5ml/min with a runtime of 5 min. The eluents were monitored using a tandem mass spectrometer equipped with an ESI in positive mode and a triple quadrupole mass analyser.
The analysis was performed in MRM mode by quantifying the ion transitions from m/z 188.0591.10; with a collision energy -29.0V for Selegiline HCl. The developed method was linear over the concentration range 3.5-6.5 ng/mL. The LOD and LOQ were found to be 2.0 ng/mL and 5.0 ng/mL, respectively. The correlation coefficient (r2) was found to be 0.9985 for Selegiline HCl.
The proposed validated LC-MS/MS method offers a sensitive quantification of selegiline hydrochloride in pharmaceutical formulation.

Key words: LC-MS/ MS, MRM, Parkinson’s disease, Selegiline HCl, Validation