Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fluvastatin Sodium in Bulk and Capsule Dosage Form
 
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1
C. K. Pithawalla Institute of Pharmaceutical Science and Research, INDIA
2
Dharamsinh Desai University, INDIA
3
Shree Dhanvantary Pharmaceutical Analysis and Research Centre (SDPARC), INDIA
CORRESPONDING AUTHOR
Ashok H. Akabari   

C.K.Pithawalla Institute of Pharmaceutical Science and Research, India
Online publication date: 2016-12-12
Publication date: 2016-12-12
 
Eurasian J Anal Chem 2017;12(2):87–105
 
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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.
 
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