Quantification of rasagiline mesylate by stability indicating RP-HPLC method: Development and validation

ABSTRACT

A novel reversed phase-high-performance liquid chromatography (HPLC) method for the estimation of rasagilinemesylate (RM), a potent anti-Parkinson drug in Active Pharmaceutical Ingredient (API), and tablet dosage form wasdeveloped and validated in the present research. HPLC instrument (Shimadzu) comprises ultraviolet detector andphenomenex 100 C18 (250 × 4.6 mm, 5 µm) column was utilized in the study. A mixture of acetonitrile and waterin the ration of 5050, adjusted to pH 3.0 ± 0.05 with ortho-phosphoric acid was used as the mobile phase. Thechromatographic conditions; flow rate 0.8 ml/minute, run time 6.0 minutes, injection volume 50 µl, and detectionwavelength 268 nm were maintained during the study at room temperature. To ensure performance of novel methoddeveloped, it was validated according to International conference on harmonization guidelines. The developed methodwas subjected to the forced degradation studies to find out the stability indicating nature of the method by quantifyingthe RM in presence of its degradation products and the peaks which were responsible for the degraded products werenot interfered with the API principle peak. The proposed stability indicating newly developed and validated methodcan be adopted for the quantification of RM in bulk and pharmaceutical formulations.