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, Leff = 58 cm and 75 µm 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 µA, 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 × 10-6 M and 2.89 × 10-6 M, respectively. Linearity in the range of 1.03 × 10-5 -5.15 × 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. Copyright © 2001 John Wiley & Sons, Ltd.