A validated LC-ESI-MS/MS method for the quantification of Selegiline HCl in bulk and pharmaceutical formulation

ABSTRACT

Selegiline HCl is an irreversible MAO-B inhibitor used to reduce symptoms in early-stage Parkinson’s disease. It isused as an adjunct to drugs, such as L Dopamine (L-DOPA). The present study is designed to develop and validatea rapid, sensitive, and straightforward separation method with Electrospray ionization and triple quadrupole massanalyzer for the quantification of Selegiline HCl in bulk and pharmaceutical formulation. Zorbax C18 column (50 mm× 4.6 mm i.d, 5 µ particle size) was used for the separation of analyte and internal standard. The samples were elutedusing 0.1% Formic acid in water and Methanol (4060%v/v) which is delivered at 0.5 ml/minute flow rate, with achromatographic runtime of 5 minutes. The eluents were monitored using a tandem mass spectrometer equipped withan electrospray ionization in positive mode and a triple quadrupole mass analyzer. The detection was carried out inmultiple reaction-monitoring mode by quantifying the m/z 188.05→91.10 ion transition pair; with collision energy−29.0 V for Selegiline HCl. Linearity was achieved over the concentration range 3.5–6.5 ng/ml for the developedmethod. The limit of detection and limit of quantification were found to be 0.2 and 0.5 ng/ml, respectively. Thecorrelation coefficient (r2) value was ≥0.9985 for Selegiline HCl. This method offers a sensitive quantification ofSelegiline HCl in the pharmaceutical formulation.