Validated analysis of fluvastatin in a pharmaceutical capsule formulation and serum by capillary electrophoresis

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.