Analytical Method Development and Validation for the Estimation of Rosuvastatin Calcium in Raw Material and Tablet Formulation by UV Spectrometric Method
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2016, Vol 2, Issue 1
Abstract
Abstract: Statins are the treatment of choice for controlling hypercholesterolemia in patients with cardiovascular risk. Although all statins are HMG-CoA reductase inhibitors, they possess different chemical structure, pharmacokinetic profile and lipid modifying efficacy. From the published literature, it is known that Rosuvastatin calcium is more effective in lowering bad cholesterol and raising good cholesterol compared to rest of statins. Extensive analytical methods for the determination of Rosuvastatin are more complex, expensive and time-consuming. So the present study is focused on development and validation of a reliable, simple and economic method for the estimation of Rosuvastatin Calcium in bulk and formulation. Analytical method development being a vital part of pre-formulation and formulation, research and development obviates the need to develop reliable and economical methods for the estimation of drugs in bulk and formulation. UV Spectroscopy is one of the earliest and widely used methods in drug analysis despite the availability of chromatographic and hyphenated techniques. A simple, precise, sensitive, accurate and economical method has been developed for the estimation of Rosuvastatin Calcium in bulk and formulation. The drug exhibits an absorption maximum at a wavelength of 240nm with 0.1N sodium hydroxide as solvent. Beer’s law is obeyed in the concentration range of 1-6µg/ml and percentage purity is found to be 98.90%. LOD and LOQ values are found to be 0.603 and 0.830µg/ml. The developed method is validated statistically as per ICH guidelines and the results obtained are within acceptance criteria related to linearity, accuracy and precision. Keywords: Rosuvastatin Calcium, Sodium Hydroxide, Hypercholesterolemia, Accuracy, Precision.
Authors and Affiliations
B. Sailaja, K. Sravana Kumari
Keywords
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