title: Validated analysis of fluvastatin in a pharmaceutical capsule formulation and serum by capillary electrophoresis.
abstract: The capillary electrophoretic behavior and the determination of fluvastatin (FLU) in capsule and serum is described in this study. Method development was conducted in a fused-silica capillary (L = 86 cm, L(eff) = 58 cm and 75 microm i.d.) and a background electrolyte consisting of 10 mM borate at pH 8 was used. The separation was performed by current-controlled system applying 41 microA, detecting at 239 nm and injecting 0.5 s vacuum injection. A good electropherogram and excellent repeatability was obtained. FLU and phenobarbital sodium (internal standard) migrated (with RSD%) at 4.8 (0.3) min and 5.2 (0.6) min, respectively. Limit of detection (LOD) and limit of quantitation (LOQ) values were found to be 1 x 10(-6) M and 2.89 x 10(-6) M, respectively. Linearity in the range of 1.03 x 10(-5) -5.15 x 10(-5) M was examined employing intra-day and inter-day studies and well-correlated calibration equations were obtained. FLU in a capsule (Lescol 40 mg declared) was found to be 41.9 +/- 0.4 mg. Furthermore, FLU was determined in serum applying standard addition technique. Good repeatability and no interference were observed. The method proposed is simple, sensitive, precise and easy to use for the determination of FLU in capsule and serum.
authors.affiliation: Department of Analytical Chemistry, Faculty of Pharmacy, University of Anadolu, 26470 Tepebaşi, Eskişehir, Turkey.
authors.forename: D
authors.initials: D
authors.lastname: Doğrukol-Ak
authors.forename: K
authors.initials: K
authors.lastname: Kircali
authors.forename: M
authors.initials: M
authors.lastname: Tunçel
authors.forename: H Y
authors.initials: HY
authors.lastname: Aboul-Enein
mesh_terms: D002214:Capsules / Q000737:chemistry*; D019075:Electrophoresis, Capillary / Q000379:methods*; D005229:Fatty Acids, Monounsaturated / Q000032:analysis* / Q000097:blood*; D000077340:Fluvastatin; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000032:analysis* / Q000097:blood*; D007211:Indoles / Q000032:analysis* / Q000097:blood*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D002214:Capsules; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D004364:Pharmaceutical Preparations; D000077340:Fluvastatin