Author(s): Swapnil D. Jadhav*, Sharad C. Sarak, Tushar S. Nimbalkar, Manish S. Bhatia and Harinath N. More

Email(s): swapnil.jadhav@bharatividyapeeth.edu

DOI: Not Available

Address: Swapnil D. Jadhav*, Sharad C. Sarak, Tushar S. Nimbalkar, Manish S. Bhatia and Harinath N. More
Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416 013, M. S. India.
*Corresponding Author

Published In:   Volume - 4,      Issue - 1,     Year - 2014


ABSTRACT:
The Tenofovir Disoproxil, Ferrous, Bisoprolol and Ketotifen were used in marketed formulations in the form of fumaric acid salt due to stability and solubility purposes. Stability of marketed formulation is an important aspect that needs special attention over the period of time. Designing of colorimetric reagent (3, 5 Dinitro Benzoic Acid) and development of analytical method has been carried out for estimation of fumaric acid from marketed formulations which indirectly quantifies Bisoprolol and Ketotifen. The fumaric acid shows linearity in concentration range of 100-700 ng/mL. The result of analysis of marketed formulation of Bisoprolol and Ketotifen we found to be within 98.00 to 102 % with RSD value of less than 2 %. The forced degradation studies of Bisoprolol and Ketotifen was carried out which shows degradation less than 20 % and results were accurate and precise. The method was validated using ICH Q2B (R1) guidelines. The method was found to be simple, accurate, precise, sensitive and selective.


Cite this article:
Designing of Colorimetric Reagent and Development of Stability Indicating Method for Analysis of Drugs with Fumarate Salt. Asian J. Pharm. Ana. 4(1): Jan.-Mar. 2014; Page 31-35.


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Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 

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