Research Article | Volume: 6, Issue: 2, February, 2016

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

Gamal H. Ragab Hanaa M. Saleh Magda M. EL-Henawee Omnia F. Elsayed   

Open Access   

Published:  Feb 27, 2016

DOI: 10.7324/JAPS.2016.60209
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.


Keyword:     Tranylcypromine sulphate stability indicating HPLC Kinetex® core shell column.


Citation:

Ragab GH, Saleh HM, EL-Henawee MM, Elsayed OF. Validated, Ultra High Efficiency RP-HPLC and Stability Indicating Method for Determination of Tranylcypromine Sulphate in Bulk and in Tablet Dosage Forms. J App Pharm Sci, 2016; 6 (02): 064-071.

Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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