Development and Validation of Stability Indicating RPHPLC Method for Estimation of Fluvastatin Sodium in Bulk and Capsule Dosage Form

Abstract

A sensitive, specific and stability-indicating reversed phase high performance liquid
chromatography-diode array detection method was developed for the quantitative
determination of fluvastatin sodium in the presence of its degradation products. The
chromatographic separation was performed on a Phenomenex Luna C18 column (150 X 4.0
mm, 5µm) in isocratic mode using acetonitrile and 0.02M potassium phosphate buffer (50
+ 50, v/v, pH 5.0 adjusted with potassium hydroxide) as the mobile phase at a flow rate of
1.0 ml/min. The quantification was performed with a photodiode array detector at 235nm
based on peak area. The method showed good linearity over the concentration range of 5-
40 µg/mL with a detection limit of 1.1µg/mL and quantification limit of 3.3µg/mL. The
proposed LC method was used to investigate the kinetics of acidic and oxidative
degradation of fluvastatin sodium. The acidic and oxidative degradation had shown an
apparent first-order kinetics and rate constants were found to be 0.0191µg/mL/min and
0.0048µg/mL/min, respectively