Volume No. :   7

Issue No. :  4

Year :  2017

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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Development and Validation of Difference Spectrophotometric Method for the Quantitative Estimation of Mesalamine in Bulk Drug and Dosage forms.



Address:   P Ravi Kumar*, Y Padmavathi , P Niveditha , N. Raghavendra Babu.
Department of Pharmaceutical Analysis and Quality Assurance, G. Pulla Reddy College of Pharmacy, Osmania University, Mehdipatnam, Hyderabad, Telangana, India.
*Corresponding Author
DOI No: 10.5958/2231-5675.2017.00036.9

ABSTRACT:
A sensitive, precise, economic spectrophotometric method i.e. a difference spectroscopic method was developed for the estimation of mesalamine in bulk and dosage (tablet and suppository) forms. Difference spectroscopic method was developed by measuring the difference absorbance of the drug in 0.1N HCl and in 0.1 N NaOH showing maximum absorbance at 330nm. Beer’s law was obeyed in the concentration range of 5-25 µg/ml. The LOD and LOQ were found to be 0.3 µg/ml and 0.9 µg/ml respectively. Correlation coefficient was observed as 0.999. The method was validated as per ICH guideline Q2R1 and the results were within the official limits. The developed difference spectroscopic method was applied for quantitative analysis of the drug in bulk and pharmaceutical dosage forms.
KEYWORDS:
Mesalamine, COX inhibitor, Difference spectroscopic method, ICH guidelines.
Cite:
P Ravi Kumar, Y Padmavathi , P Niveditha , N. Raghavendra Babu.. Development and Validation of Difference Spectrophotometric Method for the Quantitative Estimation of Mesalamine in Bulk Drug and Dosage forms. Asian J. Pharm. Ana. 2017; 7(4): 225-228.
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