Development and Validation of Difference Spectrophotometric Method for the Estimation of Fluvastatin Sodium and Bulk Dosage Form

  A new simple, accurate, precise, highly sensitive and reproducible difference spectrophotometric method for the determination of Fluvastatin in bulk and pharmaceutical dosage form is described. Difference spectroscopic method is based on the principle that Fluvastatin exhibit two different forms; in acidic and basic medium which differs in their absorption spectra. The difference spectra were obtained by reading the absorbance of Fluvastatin in 0.1N HCl in the reference cell and the absorbance of Fluvastatin in 0.1N NaOH in the sample cell and vice versa; in the difference spectrum maxima and minima were seen at 229nm and at 304nm respectively. The amplitude values were calculated, which was plotted against concentration. The method was found to be linear in the concentration range of 10-50 μg/ml. The percentage recovery was found to be between the ranges from 99.44 % to 100.45 %. The LOD & LOQ was found to be 0.215 μg/ml & 0.652 μg/ml respectively. The proposed method was statistically validated and successfully applied for analysis of Fluvastatin in capsule dosage forms. As per ICH guidelines the results of the analysis were validated statistically and were found to be satisfactory.