Abstract

Simple, sensitive, rapid and stability indicating ultra high efficiency RP-HPLC method was developed and validated for analysis of Tranylcypromine sulphate in bulk drug and in tablet dosage forms. Well-resolved peaks of the target analyte and its degradation products were achieved on a Kinetex® column (75 mm x 4.6 mm ID) 2.6 µm at 30 0C, using simple isocratic mobile phase of acetonitrile - orthophosphoric acid 0.1 % (10: 90, v/v). The flow rate was 1.0 mL/min and the detection was performed at 220 nm. The retention time of the drug was 2 min while for the reported method was 6.7 min. The method was validated according to International Conference on Harmonization (ICH) guidelines. Tranylcypromine was subjected to the stress conditions of hydrolytic acidic, basic, oxidative, and photolytic degradation. The assay was linear over the concentration range of 3-150 µg mL-1 and the correlation coefficient was 1. The RSD% of inter and intraday precision was less than 1 %. The % recoveries were found to be 100.58 % proved that the proposed method is sufficiently accurate and precise. The method distinctly separates the drug from its degradation products within 2 min and total run time of 8 min.

Key words: Tranylcypromine sulphate stability indicating HPLC; Kinetex® core shell column