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Validated High-Performance Liquid Chromatographic Method for the Estimation of Rosuvastatin Calcium in Bulk and Pharmaceutical Formulations

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Author(s): Safwan Ashour | Soulafa Omar

Journal: International Journal of Biomedical Science
ISSN 1550-9702

Volume: 7;
Issue: 4;
Start page: 283;
Date: 2011;
Original page

Keywords: rosuvastatin calcium | liquid chromatography | pharmaceutical dosage form

ABSTRACT
A reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of rosuvastatin calcium in pharmaceutical dosage forms. The determination was performed on a Nucleodur column C8 (250 × 4.6 mm i.d., 5 μm particle size); the mobile phase consisted of a mixture of 0.1Mformic acid and methanol (25:75, v/v), pumped at a flow rate 1.0 mL min−1. The photodiode array detector was operated at 280 nm. The retention times for rosuvastatin and fluvastatin, which was used as internal standard, were 3.98 and 7.78 min, respectively. Linearity range (r2better than 0.999, n=6) was 3.0-1602.0 μg mL-1 with limit of detection value of 0.12 μg mL-1. The precision of the method was demonstrated using intra- and inter-day assay RSD% values which were less than 2.40%, while the recovery was 99.86-102.86%. The method was applied in the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.

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