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.

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

“…The sensitivity of this study was similar when compared with those of in literature findings for the assay of FLU in pharmaceutical preparations. [15][16][17][18][19] No peak was found at the retention time of FLU in placebo solution. The good recoveries of FLU were in the range of 99.25-99.80% in determining of the accuracy of the method (Table 2).…”

“…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. The antioxidant effects of FLU have also been studied in humans [20][21][22] and animals.…”

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fluvastatin Sodium in Bulk and Capsule Dosage Form

“…First derivative spectrophotometry [7] and kinetic spectrophotometric [8] determination of fluvastatin in pharmaceutical preparations have been reported. FVS have been determined by capillary electrophoresis [9] (CE), high performance liquid chromatography (HPLC) in biological fluids such as human and rat plasma [10][11][12][13][14][15][16][17]. Liquid chromatography-mass spectrometry [18][19] and gas chromatography-mass spectrometry [20] have been reported for the determination of FVS in biological fluids.…”

RP‐HPLC Determination of Three Anti‐Hyperlipidemic Drugs in Spiked Human Plasma and in Dosage Forms

“…Few methods have been reported for the determination of fluvastatin,(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid including spectrophotometry 22 , HPLC methods with ultraviolet (UV) detection 23 , fluorometric detection 24,25 and tandem mass spectrometry detection 14 , GC-MS 26 , voltammetric 27 and capillary electrophoresis 28 . Several methods have been developed for the estimation of pravastatin in dosage forms and biological fluids including, HPLC methods, with UV detection [29][30][31][32][33] and tandem mass spectrometry detection 14,34 , LC-MS 35,36 , 1 H NMR 37 , voltammetric 38 and polarographic 39 .…”