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


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1 Department of Pharmaceutical Analysis and Quality Assurance, G. Pulla Reddy College of Pharmacy, Osmania University, Mehdipatnam, Hyderabad, Telangana, India
     

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

Abstract Views: 363  |  PDF Views: 0

Authors

P. Ravi Kumar
Department of Pharmaceutical Analysis and Quality Assurance, G. Pulla Reddy College of Pharmacy, Osmania University, Mehdipatnam, Hyderabad, Telangana, India
Y. Padmavathi
Department of Pharmaceutical Analysis and Quality Assurance, G. Pulla Reddy College of Pharmacy, Osmania University, Mehdipatnam, Hyderabad, Telangana, India
P. Niveditha
Department of Pharmaceutical Analysis and Quality Assurance, G. Pulla Reddy College of Pharmacy, Osmania University, Mehdipatnam, Hyderabad, Telangana, India
N. Raghavendra Babu
Department of Pharmaceutical Analysis and Quality Assurance, G. Pulla Reddy College of Pharmacy, Osmania University, Mehdipatnam, Hyderabad, Telangana, India

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.

References