Validated, Ultra High Efficiency RP-HPLC and Stability Indicating Method for Determination of Tranylcypromines Sulphate in Bulk and in Tablet Dosage Forms

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 target analyte and its degradation products were achieved on a Kinetex ® column (75 mm x 4.6 mm ID) 2.6 µm at 30 °C , 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.

Discrimination Between Drug Abuse and Medical Therapy: Case report of a tranylcypromine overdose-related fatality

“…12 Ragab et al noted that tranylcypromine is relatively stable on exposure to ultraviolet light and that only small amounts of degradation products can be detected using reversed-phase HPLC; the authors concluded that the cyclopropyl ring opens in both acidic and alkaline conditions and that the degradation products have different chemical structures from amphetamine and methamphetamine. 17 One possible explanation for the discrepancies in the findings of the aforementioned studies may be individual variations in drug metabolism among patients. For example, ethnic variations in cytochrome P450 isoenzymes have resulted in differing levels of metabolic activity, clinical responses and drug interactions.…”

Interaction Studies of Chlorpheniramine Maleate in Mono and Dihydric Alcohols by Density, Viscosity, and HPLC Methods

“…The chromatographic analysis was carried out according to the reported method [19]. Chromatographic condition is based on isocratic elution mode at ambient temperature.…”