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Pharmaceutics
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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN AND NIACIN IN BULK AND COMBINED TABLET DOSAGE FORM BY USING UV?VISIBLE SPECTROSCOPY


Abstract

Author(s): Ramreddy Godela, Suresh , Shivakumareddy Rakasi, Vikram S.

A simple, precise, rapid and sensitive UV spectrophotometric method was developed and validated for estimation of Niacin (NCN) and Atorvastatin (ATR) in pure and tablet dosage form using methanol: water (10:90 v/v) mixture as solvent by simultaneous equation method. The absorption maxima were found to be 257nm and 242 nm for Niacin and Atorvastatin calcium respectively. Beer’s law range was in the concentration range of 10-60 μg/ml for Niacin and 5-30 μg/ml for Atorvastatin calcium with correlation coefficient within the range of 0.997 – 0.998 for both the drugs. Recovery studies were performed to assess the accuracy of the methods, the results were found to be between 99.8% to100.1% for Atorvastatin and 98.75% to 100.6% for Niacin. LOD and LOQ were found to be 0.366 µg/ml and 1.1 µg/ml for Atorvastatin and 1.65 µg/ml and 5.0µg/ml for Niacin. Robustness was done by slightly changing the solvent composition and λmax. The above method has been validated according to ICH guidelines. Hence the above methods can be used for routine analysis of Niacin and Atorvastatin in pharmaceutical industries.

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