Abstract
A normal-phase TLC method has been established for the estimation of rosuvastatin calcium in its bulk drug and pharmaceutical formulations. Analysis was performed in a Camag twin-trough chamber on silica gel 60F 254 HPTLC plates. Aceclofenac was used as internal standard. The optimized mobile phase was toluene-metha nol-ethyl acetate-formic acid, 6.0 + 1.0 + 3.0 + 0.1 ( v/v ). Quantitation was performed densitometrically at λ = 265 nm. A good correlation coefficient ( r 2 = 0.9999) was obtained for the linearity for amounts of sample in the range 1.0 to 15.0 μg. The assay was performed using methanol as solvent for both the formulation and the bulk drug. For formulation and bulk drug the mean percentage assay was 100.09 ± 0.20 and 100.07 ± 0.48, respectively. The accuracy of the method was found to be 100.62% and precision was found to be vary from 0.01% to 0.77%. The procedure was simple and rapid and the results were reliable.
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