Stereoselective analysis of fluvastatin in human plasma for pharmacokinetic studies

Lanchote, Vera Lúcia; Rocha, Adriana; Albuquerque, Flávio Ulliana Vieira de; Coelho, Eduardo Barbosa; Bonato, Pierina Sueli

doi:10.1016/s0378-4347(01)00407-8

Cited by 23 publications

(22 citation statements)

References 14 publications

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“…[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.…”

Section: Fluvastatin (Flu) (3r5s6e)-rel-7-[3-(4-fluorophenyl)-1-(1mentioning

confidence: 99%

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

Aslan¹,

Ersoy²

2009

Quím. Nova

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Recebido em 1/12/08; aceito em 24/5/09; publicado na web em 30/10/09 A gas chromatographic method has been developed for the assay of fluvastatin sodium (FLU). FLU was silylated with N,Obis(trimethylsilyl)trifluoroacetamide-1% trimethylchlorosilane at 90 ºC for 30 min and analysed in a DB-1 column by capillary gas chromatograph with a flame ionization detector. The method was validated. The assay was linear over the concentration range at 10.0 to 50.0 mg mL -1. The limit of detection and the limit of quantitation were 1.0 and 3.0 mg mL -1 , respectively. The recoveries of FLU derivatives were in the range of 99.25-99.80%. In inter-day and intra-day analysis, the values of relative standard deviation (%) and the relative mean error (%) were found between 0.20-0.80% and -0.20-0.75%, respectively. The developed method was succesfully applied to analyze the FLU content in tablet formulation. The results were statistically compared with those obtained by the official method, and no significant difference was found between the two methods. Therefore, it can be recommended for the quality control assay of FLU in pharmaceutical industry.

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Section: Fluvastatin (Flu) (3r5s6e)-rel-7-[3-(4-fluorophenyl)-1-(1mentioning

confidence: 99%

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

Aslan¹,

Ersoy²

2009

Quím. Nova

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“…The migration order of fluvastatin enantiomers was identified by injecting separate fluvastatin enantiomers to the CE system and comparing with the elution order of them on the chromatography using Chiralcel OD-H column which was reported (Lanchote et al, 2001). The result shows that (+)-3R, 5S-fluvastatin migrates faster to the detector than (-)-3S, 5R-fluvastatin does when both HP-β-CD and A-β-CD were used as chiral selectors and under the experimental conditions.…”

Section: Investigation Of the Chiral Separation Of Fluvastatin Enantimentioning

confidence: 99%

Chiral separation of fluvastatin enantiomers by capillary electrophoresis

et al. 2008

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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.

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“…In the second report, the authors described a highly sensitive method for the analysis of FV enantiomers in plasma using solid phase extraction (C2), enantiomer separation through a Chiralcel ® OD-R column and a fluorescence detection after post-column exposure of the eluate to UV light, which enhanced the sensitivity 10-fold. We have previously reported the enantioselective kinetic disposition of FV administered to a healthy volunteer [5], showing higher plasma concentrations for the (−)-3S,5R-FV enantiomer. LC-18 Supelclean columns and the enantiomers were separated by HPLC on a Chiralcel OD-H chiral phase column and detected by fluorescence.…”

Section: Introductionmentioning

confidence: 96%

Chiral evaluation of fluvastatin in human plasma by high-performance liquid chromatography electrospray mass spectrometry

Pietro

Coelho

Geleilete

et al. 2006

Journal of Chromatography B

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Stereoselective analysis of fluvastatin in human plasma for pharmacokinetic studies

Cited by 23 publications

References 14 publications

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

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

Chiral separation of fluvastatin enantiomers by capillary electrophoresis

Chiral evaluation of fluvastatin in human plasma by high-performance liquid chromatography electrospray mass spectrometry

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