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ABSTRACT
| Title |
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NEW ANALYTICAL METHODS AND THEIR VALIDATION FOR THE ESTIMATION OF METOPROLOL SUCCINATE IN BULK AND MARKETED FORMULATION |
| Authors |
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Viral Bechara, EVS Subrahmanyam, Ramakrishna Shabaraya |
| Keywords |
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Metoprolol succinate, Malachite green, ß-naphthol, validation and colourimetry. |
| Issue Date |
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February 2015 |
| Abstract |
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Metoprolol succinate 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 metoprolol succinate in bulk and marketed formulations. Method A is based on oxidation reaction. Metoprolol succinate in presence of acidic medium reacts with excess amount of chloramine-T and remaining chloramine-T react with malachite green to produce orange colour chromogen which showed ?max at 516 nm. In Method B, the drug was diazotised with sodium nitrite in presence of hydrochloric acid and then it was coupled with ß-naphthol in alkaline medium. Which produce red colour chromogen which showed ?max at 688 nm. Results: The linearity was found in concentration range of 5-30µg/ml for both method A and method B. The correlation coefficient was found to be 0.9983 and 0.9993 for method A and method B respectively. The methods were validated as per ICH guidelines. The LOD and LOQ for estimation of Metoprolol succinate were found as 0.0773, 0.2343 for method A and 0.0667, 0.2021 for method B respectively. Conclusion: Proposed methods were successfully applied for the quantitative estimation of Metoprolol succinate in marketed formulations. |
| Page(s) |
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425-428 |
| ISSN |
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0975-9492 |
| Source |
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Vol. 6, No.2 |
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