HPLC assay and pharmacokinetic study of atorvastatin in beagle dogs after oral administration of atorvastatin self-microemulsifying drug delivery system

• Published in: Pharmazie Vol. 61; no. 1; pp. 18 - 20
• Main Authors: Shen, Hai-Rong, Li, Zhong-Dong, Zhong, Ming-Kang
• Format: Journal Article
• Language: English
• Published: Germany Govi-Verlag 01.01.2006
• Subjects: Animals; Atorvastatin Calcium; Chromatography, High Pressure Liquid; Dogs; Drug Delivery Systems; Emulsions; Heptanoic Acids - administration & dosage; Heptanoic Acids - pharmacokinetics; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacokinetics; Indicators and Reagents; Male; Pyrroles - administration & dosage; Pyrroles - pharmacokinetics; Reproducibility of Results; Spectrophotometry, Ultraviolet
• ISSN: 0031-7144

A specific and accurate reversed-phase HPLC with UV detection was developed for the assay of atorvastatin in beagle dog plasma. Indomethacin was used as the internal standard. Atorvastatin was extracted by protein precipitation, the extracts were injected into a Kromasil C8 column (150 mm × 4.6 mm, 5 μm) with UV wavelength set at 270 nm. The mobile phase consisted of acetonitrile : 0.1 mol/L ammonium acetate buffer (pH 4.0) (65 : 35% v/v) at a flow rate of 1.0 ml/min. The column was at ambient temperature (25 °C). The injection volume was 25 μl. The blank plasma did not interfere with the determination of atorvastatin and indomethacin. A good linear relationship was obtained between the peak area ratio of atorvastatin to indomethacin and the concentration of atorvastatin over the range of 0.05 to 2.5 μg/mL. The limit of quantification was 25 ng/mL, the limit of detection was 8 ng/ml. The total chromatographic analysis time was within 9 min. The method is accurate, precise and fast for the assay of atorvastatin in plasma following oral administration of an atorvastatin SMEDDS to healthy beagle dogs.