Volume No. :   5

Issue No. :  1

Year :  2015

ISSN Print :  2231-5667

ISSN Online :  2231-5675


Registration

Allready Registrered
Click to Login

In vitro Comparative Forced Degradation Study of Different Brands and Active form of Montelukast sodium using UV Spectrophotometer



Address:   Md. Jakaria*, Md. Hazrat Ali, Md. Areeful Haque, Mohammed Abu Sayeed, Shoayeb Ahmed
Department of Pharmacy, International Islamic University Chittagong (IIUC), Chawkbazar, Chittagong-4203, Bangladesh
*Corresponding Author
DOI No: 10.5958/2231-5675.2015.00005.8

ABSTRACT:
The objective of this study was to develop the degradation studies of different brands of montelukast sodium in the market and its active form. Forced degradation is a process that involves degradation of drug products and drug substances at conditions more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. Montelukast Sodium (1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl) ethenyl] phenyl]-3-[2-(1-hydroxy-1- methylethyl) phenyl] -propyl] thio] methyl] cyclopropaneacetic acid, monosodium salt is a white colored powder and it is freely soluble in ethanol, methanol, and water. It is a leukotriene receptor antagonist and, used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies This drug was subjected to different stress conditions as per International Conference on Harmonization guidelines (ICH). An ultraviolet UV spectroscopic method was developed for analysis of the drug in the presence of the degradation products. Methanol was used as a solvent. The amount of degraded drugs was calculated by taking the absorbance at 285 nm. According to the assay limit of USP specified that the content should not be less than 95% and not more than 105% of labelled amount. All brands and its active form were degraded on basic pH and on acidic pH. In addition to heat exposure all brands and active form were also degraded. It was concluded that all brands and active form of montelukast degraded from ranges for all the stresses applied for degradation studies.
KEYWORDS:
Degradation studies, cyclopropaneacetic acid, montelukast sodium, leukotriene receptor, assay.
Cite:
Md. Jakaria, Md. Hazrat Ali, Md. Areeful Haque, Mohammed Abu Sayeed, Shoayeb Ahmed. In vitro Comparative Forced Degradation Study of Different Brands and Active form of Montelukast sodium using UV Spectrophotometer. Asian J. Pharm. Ana. 5(1): Jan.- March 2015; Page 26-30.
[View HTML]      [View PDF]



Visitor's No. :   96769