Sensitive Assay for the Determination of Fluvastatin in Plasma Utilizing High-Performance Liquid Chromatography With Fluorescence Detection

Abstract

The authors describe a rapid, useful, specific, and very sensitive high-performance liquid chromatographic assay for the determination of fluvastatin (FV) level using atorvastatin as the internal standard (IS). After a simple deproteinization of 1.0 mL of plasma with acetonitrile, the drug and IS were extracted with tert-methyl butyl ether (TMBE). An efficient separation was performed using an 8 mm x 10 cm Nova Pak C(18) 4-microm particle size radial compression cartridge. The mobile phase consisted of an aqueous solution containing 20 mmol/L dibasic sodium dihydrogen phosphate with 1 mmol/L sodium lauryl sulfate adjusted to pH 7 with phosphoric acid and acetonitrile (70:30 v/v) delivered at a flow rate of 1.0 mL/min. The compounds of interest were detected using a fluorescence detector with the excitation wavelength set at 305 nm and the emission at 380 nm. Under these conditions, the retention times for FV and IS were 8.8 and 10.6 minutes, respectively. The concentration of FV in plasma was linear (r > 0.999) for the wide range that was examined (0.5-1,000 ng/mL). The recovery ranged from 88% to 96%. This sensitive, rapid, and simple analytical method gives accurate results over the wide range of concentrations examined. This method is used currently for clinical therapeutic monitoring and pharmacokinetic studies of FV in patients with hypercholesterolemia.

Possible Mechanisms Underlying Statin-Induced Skeletal Muscle Toxicity in L6 Fibroblasts and in Rats

“…After 72 h of infusion, plasma fluvastatin concentration was determined using a high-performance liquid chromatography (HPLC) system equipped with a UV detector (17). The column used was a WAKOPAK Handy ODS (4.6 mmø × 250 nm), and the mobile phase consisted of an aqueous solution containing 20 mM dibasic sodium dihydrogen phosphate with 1 mM sodium lauryl sulfate adjusted to pH 7 with phosphoric acid and acetonitrile (70:30 v / v).…”

Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations

“…[1][2][3][4] FLU is used in the treatment of hypercholestrolemia, 5,6 and treatment with statin drugs decreases the risk of cardiovascular diseases, in addition to mortality. 7 FLU has been determined by high performance liquid chromatographic methods with UV detection, 8 fluorometric detection [9][10][11][12] and mass spectrometric detection 13,14 in human plasma. A few methods such as spectrophotometric, 15 electrometric 16,17 and electrophoretic 18,19 have been reported for the assay of FLU in pharmaceutical preparations.…”

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

“…First derivative spectrophotometry [7] and kinetic spectrophotometric [8] determination of fluvastatin in pharmaceutical preparations have been reported. FVS have been determined by capillary electrophoresis [9] (CE), high performance liquid chromatography (HPLC) in biological fluids such as human and rat plasma [10][11][12][13][14][15][16][17]. Liquid chromatography-mass spectrometry [18][19] and gas chromatography-mass spectrometry [20] have been reported for the determination of FVS in biological fluids.…”