An LC-MS/MS method was developed and validated for the determination of Rasagiline in human plasma. Rasagiline d6 was used as an internal standard (IS). The plasma samples were extracted by simple solid phase extraction method. These samples were then chromatographed on a C18 column by using a mixture of 5Mm ammonium acetate (pH 3.5) and acetonitrile (20:80, v/v) as the mobile phase. The method was validated in the range of 0.51–100.9 ng/mL with r2 = 0.99. The intra–day and inter–day precision and accuracy results in four validation batches across five concentration levels were well within the acceptance limits.

A High performance liquid chromatography mass spectrometric method for the estimation of Rasagiline, in human plasma in Positive ion mode was developed and validated using Rasagiline 13C3 as internal standard (IS). Sample preparation was accomplished by solid-phase extraction technique. The eluted samples were chromatographed on Zorbax C18, 50*4.6 mm, 3.5µM (Make: Agilent Technologies) column using a mobile phase consisting of HPLC grade acetonitrile: methanol: 5mM ammonium bicarbonate (75:20:05, v/v/v).

The method was validated over a concentration range of 0.010 ng/mL to 12.155 ng/mL for Rasagiline. This validation report provides the results of the analyte and matrix selectivity, matrix effect, sensitivity, calibration standards and quality control samples data, precision and accuracy data, the results of recovery, various stability data, run size evaluation and dilution integrity along with all pertinent documentation.  

KEYWORDS: Rasagiline; Human plasma; Solid-phase extraction (SPE); LC–MS/MS.