Asian Journal of Pharmaceutical Analysis

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


Affiliations
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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  • KD Tripathi, Essentials of Medical pharmacology. Jaypee Brothers Medical publishers, New Delhi. 2013; 7th Ed.

  • Indian pharmacopoeia, vol II. Indian pharmacopoeialcommision, Ghaziabad .2014.

  • HP Rang, MM Dale, JM Ritter, RJ Flower, G. Henderson. Pharmacology, Spain: Elsevier Churchil Livingstone, 2012. 7th Ed.

  • GR Chatwal, SK Anand. Instrumental Methods of Chemical Analysis., Himalaya publishing House, 2002; 5th Ed.

  • A.H Beckett, J.B Stenlake. Practical pharmaceutical chemistry, part two. CBS Publishers, New Delhi.2004.

  • YR Sharma. Elementary Organic Spectroscopy. Instrumental methods of chemical analysis. S. chand and Company ltd; 2011.

  • Skoog, Holler, Nieman. Principles of Instrumental Analysis. Baba BarkhaNath printers; 2007;6th Ed.

  • Pavia, Lampman, Kriz, Vyvyan. Introduction to spectroscopy. Brookescole, 2011.

  • Moharana Ak, Banerjee M, Panda S. Development and validation of UV spectrophotometric method for the determination of mesalamine in bulk and tablet formulation. International journal of pharmacy and pharmaceutical sciences. 2010; 3(2).

  • Sasmita Acharjya, Aloksahu, Srikanta Das. Spectrophotometric methods for the determination of Mesalamine in bulk and pharmaceutical dosage forms. Journal of pharmaceutical Education and Research, 2010.

  • Venugopal R Darak, Aravind B Karadi, MD Arshad and Sajja Appalraju. Development and Validation of Visible Spectrophotometric methods for the Estimation of Mesalamine in Pharmaceutical Dosage Forms. Available online at: http://derpharmachemica.com/archive.html, 2011, 3(2): 342-346.

  • Ravi Kumar P, Vijaya Bharathi, Padamavathi Y, Raghavendra Babu and Sheryl Andrews. Development and Validation of new spectrophotometric methods for quantitative estimation of esomeprazole in bulk and dosage forms. Inventi Impact:Pharma Analysis and Quality Assurance, 2016(3):56-62.

  • International Conference on Harmonization, Q2 (R1): Validation of Analytical Procedures; Text and methodology. 1997; 62 (96): 27463-67.


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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: 776  |  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