D. Dogrukol-ak et al., Validated analysis of fluvastatin in a pharmaceutical capsule formulation and serum by capillary electrophoresis, BIOMED CHRO, 15(6), 2001, pp. 389-392
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
mum i.d.) and a background electrolyte consisting of 10 mM borate at pH 8 w
as used. The separation was per-formed by current-controlled system applyin
g 41 muA, detecting at 239 nm and injecting 0.5 s vacuum injection. A good
electropherogram and excellent repeatability was obtained. FLU and phenobar
bital sodium (internal standard) migrated (with RSD%) at 4.8 (0.3) min and
5.2 (0.6.) min, respectively. Limit of detection (LOD) and Iii-nit of quant
itation (LOQ) values were found to be 1 x 10(-6) M and 2.89 x 10(-6) M, res
pectively. Linearity in the range of 1.03 x 10(-5) -5.15 x 10(-5) M was exa
mined employing intra-day and inter-day studies and well-correlated calibra
tion equations were obtained. FLU in a capsule (Lescol(R) 40 mg declared) w
as found to be 41.9 +/-0.4 mg. Furthermore, FLU was determined in serum app
lying standard addition technique. Good repeatability and no interference w
ere observed. The method proposed is simple, sensitive, precise and easy to
use for the determination of FLU in capsule and serum. Copyright (C) 2001
John Wiley & Sons, Ltd.