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

Eurasian Journal of Analytical Chemistry

关键词: fluvastatin;    kinetic study;    stability indicating method;    anti hyperlipidemic agent;    development and validation;   

DOI  :  10.12973/ejac.2017.00156a

学科分类：分析化学

来源: Eurasian Journal of Analytical Chemistry

【 摘 要 】

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.

【 授权许可】

Unknown