Chiral separation of fluvastatin enantiomers by capillary electrophoresis

Abstract

An analytical CE method was developed for the enantiomeric purity determination of fluvastatin enantiomers. Fluvastatin enantiomers were separated on an uncoated fused silica with 100 mM-borate solution containing 30 mg/mL of (2-hydroxypropyl)-beta-cyclodextrin (HP-beta-CD) as running buffer and fenoprofen as an internal standard. The linearity was observed within a 400-700 microg/mL concentration range (r(2)>or=0.995) for both fluvastatin enantiomers. The repeatability expressed as coefficient of variation (CV) of the method were 0.96 and 0.92% for (+)-3R, 5S and (-)-3S, 5R-fluvastatin, respectively. The limit of detection and quantification for both fluvastatin enantiomers were 1.5 microg/mL and 2.5 microg/mL, respectively.

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

“…The CE method was developed for the enantiomeric purity determination of fluvastatin enantiomers [117]. Its principle involves the formation of diastereoisomer complexes after addition of neutral cyclodextrin to the running buffer.…”

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

“…The sensitivity of this study was similar when compared with those of in literature findings for the assay of FLU in pharmaceutical preparations. [15][16][17][18][19] No peak was found at the retention time of FLU in placebo solution. The good recoveries of FLU were in the range of 99.25-99.80% in determining of the accuracy of the method (Table 2).…”

“…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. The antioxidant effects of FLU have also been studied in humans [20][21][22] and animals.…”

Chiral selectors in CE: Recent developments and applications

“…2‐HP‐β‐CD seems to be the most widely applicable neutral CD derivative. It was used for the enantiomeric separation of amino acids, in combination with SDS and PEO , and chiral drugs, such as fluvastatin , β 2 ‐agonists , etodolac , the antimycotic drugs, ketoconazole and terconazole , and lodipine . This is due to its excellent solubilizer features and its excellent selectivity because of its polar and nonpolar substituent groups and the extra chiral centers that these groups provide.…”