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ABSTRACT
| Title |
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NEW ANALYTICAL METHODS AND THEIR VALIDATION FOR THE ESTIMATION OF CARVEDILOL IN BULK AND MARKETED FORMULATION |
| Authors |
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Viral Bechara, EVS Subrahmanyam, Ramakrishna Shabaraya |
| Keywords |
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Carvedilol, potassium ferricyanide, ferric ammonium sulphate, 2, 4-dinitro phenyl hydrazine, sodium hydroxide, potassium iodate, validation and colourimetry. |
| Issue Date |
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February 2015 |
| Abstract |
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Carvedilol is cardiovascular agent. Mainly used for the treatment of hypertension, heart failure, and cardiovascular diseases. Purpose: Analytical methods are required to characterize drug substances and drug products composition during all phases of pharmaceutical development. Development of methods to achieve the final goal of ensuring the quality of drug substances and drug products must be implemented in conjunction with an understanding of the chemical behavior and physicochemical properties of the drug substance. This determination requires highly sophisticated instruments and methods like HPLC, HPTLC and Spectrophotometer. Hence there was a need for the development of newer, simple, sensitive, rapid, accurate and reproducible analytical methods for the routine estimation of metoprolol succinate in bulk and pharmaceutical dosage form. Methods: The present work describes two new spectrophotometric methods for the determination of carvedilol in bulk and marketed formulations. Method A is based on oxidation of Carvedilol with ferric ammonium sulphate followed by complex formation of resulting ferrous ion (Fe2+) with potassium ferricyanide to form bluish green coloured chromogen which showed ?max at 582 nm. In Method B is based on the oxidation of 2, 4-Dinitrophenylhydrazine and coupling of the oxidized product with drugs to give brown coloured chromogen which showed ?max at 500.8 nm. Results: The linearity was found in concentration range of 5-30 µg/ml for both Method A and Method B. The correlation coefficient was found 0.997 and 0.9997 for both Method A and Method B respectively. The methods were validated as per ICH guidelines. The LOD and LOQ for estimation of Carvedilol were found as 0.0840, 0.2545 for method A and 0.0667, 0.2021 for method B respectively. Conclusion: Proposed methods were successfully applied for the quantitative estimation of Carvedilol in marketed formulations. |
| Page(s) |
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421-424 |
| ISSN |
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0975-9492 |
| Source |
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Vol. 6, No.2 |
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