Research Article | Volume: 7, Issue: 5, May, 2017

A Validated Stability Indicating Reversed Phase High Performance Liquid Chromatographic Method of Leflunomide and Characterization of Its Degradation Products through Retro-Synthesis

Tapas Kumar Laha Subrata Sen   

Open Access   

Published:  May 30, 2017

DOI: 10.7324/JAPS.2017.70503
Abstract

The present paper deals with the development of stability indicating a reversed phase high-performance liquid chromatographic (RP-HPLC) method for leflunomide, a disease-modifying antirheumatic drug in presence of its degradation products formed during forced decomposition studies. Forced degradation studies were performed on the bulk drug by using acid (0.1 N hydrochloric acid), base (0.1 N sodium hydroxide), water (neutral hydrolysis), 3% v/v hydrogen peroxide (oxidation), dry heat (60°C) and UV light (254 nm). Degradation was observed for leflunomide in acidic and basic media only and the formed degradation products were found to be 5-methylisoxazole-4-carboxylic acid (degradation product-1) and 4-(trifluoromethyl)-aniline (degradation product-2). Successful separation of the drug from the degradation products formed under different stress conditions was achieved on a Novapak C18 column (150 mm × 3.9 mm, 4 µm particle size) using methanol- phosphate buffer (pH 5.3; 20 mM) (7:3, v/v) as the mobile phase at a flow rate of 1 mL/min. The detection wavelength was 260 nm. The developed method was completely validated and proved to be robust. As the method could effectively separate the drug from its degradation products, it can be employed for analysis of the samples of stability study.


Keyword:     HPLC Leflunomide Stability Synthesis Characterization FTIR Mass Spectrometry NMR spectroscopy.


Citation:

Laha TK, Sen S. A Validated Stability Indicating Reversed Phase High Performance Liquid Chromatographic Method of Leflunomide and Characterization of Its Degradation Products through Retro-Synthesis. J App Pharm Sci, 2017; 7 (05): 012-017.

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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