Abstract: A new, simple, precise, accurate and economical and sensitive spectrophotometric method in ultraviolet region has been developed for the determination of rosuvastatin calcium in bulk and in pharmaceutical formulation. The drug exhibits an absorption maximum at a wavelength of 242 nm with Acetonitrile: Methanol (60:40v/v) as diluents. Linearity of rosuvastatin calcium was observed in the concentration range of 4-24μg/ml. Percentage purity and accuracy were in the limit of 98%-102%.The method was found precise (% RSD< 2%). The Correlation coefficient for drug methods was greater than 0.99. Percentage purity is found to be 100.21%.LOD and LOQ values are found to be 0.75 and 2.27μg/ml. The assay was found to be in range of 99.77%-101.81% .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, Methanol, Acetonitrile, UV spectrophotometric method, Validation.
Title: Development and Validation of Spectrophotometric Method for the Determination of Rosuvastatin Calcium in Solid Dosage Form and Pharmaceutical Formulation
Author: Priyanka Pannure, Vaishali B Jadhav, Ashish Jain
International Journal of Thesis Projects and Dissertations (IJTPD)
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