Asian Journal of Pharmaceutical Analysis

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Designing of Colorimetric Reagent and Development of Stability Indicating Method for Analysis of Drugs with Fumarate Salt


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1 Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416 013, M. S., India
     

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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.
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  • Designing of Colorimetric Reagent and Development of Stability Indicating Method for Analysis of Drugs with Fumarate Salt

Abstract Views: 270  |  PDF Views: 1

Authors

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

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.