Journal :   Asian Journal of Research in Chemistry

Volume No. :   11

Issue No. :  6

Year :  2018

Pages :   871-875

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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New, Sensitive, Simple and Validated Stability Indicating TLC/Densitometric Method for the Estimation of Anti-Ulcer Drug Mesalamine in Bulk and Tablet Formulation



Address:   Mohammad Mojeeb Gulzar Khan1*, Atul Arun Shirkhedkar2
1Assistant Professor, Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur, Dist: Dhule (MS) India 425405
2Professor, Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur, Dist: Dhule (MS) India 425405
*Corresponding Author
DOI No: 10.5958/0974-4150.2018.00152.9

ABSTRACT:
Mesalamine is use in the treatment of ulcerative colitis (a health disorder which causes swelling and sores in the lining of the colon [large intestine] and rectum) and also to improve ulcerative colitis symptoms. Solubility of drug in volatile solvent is important criteria for development of TLC method. The presented work explains the development and validation of TLC/Densitometric method for Mesalamine by using accurate solvent for solubility of Mesalamine. Precoated TLC aluminium plates were utilized as a stationary phase and mobile phase composed of Toulene: Methanol: Triethylamine: (05: 05:0.1 v/v/). Densitometric analysis for the Mesalamine is carried out at ?max 325. Method validation was performed as per ICH Guidelines. Stress degradation study was done under various reaction conditions. This system was found to give compact spots for Mesalamine at Rf value 0.63 ± 0.02. The data of linear regression analysis of Mesalamine signify a good linear relationship over the range of 400 –2400 ng/band. LOD and LOQ found 37.66 and 114.14 ng for Mesalamine indicates sensitivity of the method. Resulted stress drugs were analyzed with the developed TLC/ densitometry method. HPTLC method for Mesalamine has been developed by using proper volatile solvent as it is need of study. Statistical analysis verifies that the method is repeatable and selective for the determination of Mesalamine drug in bulk and in Pharmaceutical formulation. As the method could effectively separate the drug from its degradation products, it can be considered as a stability- indicating method.
KEYWORDS:
Mesalamine, TLC, Densitometry, Validation, Stability Indicating.
Cite:
Mohammad Mojeeb Gulzar Khan, Atul Arun Shirkhedkar. New, Sensitive, Simple and Validated Stability Indicating TLC/Densitometric Method for the Estimation of Anti-Ulcer Drug Mesalamine in Bulk and Tablet Formulation. Asian J. Research Chem. 2018; 11(6):871-875.
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