Quantification of rasagiline mesylate by stability indicating RP-HPLC method: Development and validation
Journal of Applied Pharmaceutical Science
A novel reversed phase-high-performance liquid chromatography (HPLC) method for the estimation of rasagiline mesylate (RM), a potent anti-Parkinson drug in Active Pharmaceutical Ingredient (API), and tablet dosage form was developed and validated in the present research. HPLC instrument (Shimadzu) comprises ultraviolet detector and phenomenex 100 C18 (250 × 4.6 mm, 5 µm) column was utilized in the study. A mixture of acetonitrile and water in the ration of 50:50, adjusted to pH 3.0 ± 0.05 with
... pH 3.0 ± 0.05 with ortho-phosphoric acid was used as the mobile phase. The chromatographic conditions; flow rate 0.8 ml/minute, run time 6.0 minutes, injection volume 50 µl, and detection wavelength 268 nm were maintained during the study at room temperature. To ensure performance of novel method developed, it was validated according to International conference on harmonization guidelines. The developed method was subjected to the forced degradation studies to find out the stability indicating nature of the method by quantifying the RM in presence of its degradation products and the peaks which were responsible for the degraded products were not interfered with the API principle peak. The proposed stability indicating newly developed and validated method can be adopted for the quantification of RM in bulk and pharmaceutical formulations.