Determination of saterinone enantiomers in plasma samples with an internal standard using a Chiralcel OD column, fractionation and reversed-phase chromatography.
A specific and validated high-performance liquid chromatographic method was developed for the determination of the S-(-) and R-(+) enantiomers of saterinone. 1-[(4-cyano-1,2-dihydro-6-methyl-2-oxopyridin-5-yl)phenoxyl] -3-[4-(2- methoxyphenyl)piperazin-1-yl]propan-2-ol, in plasma at the low ng/ml level. The enantiomers of saterinone and an internal standard, 1-[(4-cyano-1,2-dihydro-6-methyl-2-oxo-pyridin-5-yl)phenoxy]-3-[4-(2- ethoxyphenyl)piperazin-1-yl]propan-2-ol, were chromatographed on a chiral Chiralcel OD stationary phase. However, the S-(-) enantiomers of saterinone and the internal standard were unresolved, as were the R-(+) enantiomers of both substances. Therefore, the two fractions were collected and each was separately resolved on an achiral Polyencap A reversed-phase column and quantified. The detection limit was 0.5 ng/ml of enantiomer, allowing the determination of plasma levels up to 36 h after oral administration of 90, 150 and 180 mg of saterinone to twelve subjects.
Rudolph
M
M
Pharmaceutical Development, Beiersdorf AG, Hamburg, F.R.G.
Volk
D
D
Schmiedel
G
G
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002316:Cardiotonic Agents / Q000008:administration & dosage / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008297:Male; D010879:Piperazines / Q000008:administration & dosage / Q000097:blood*; D011728:Pyridones / Q000008:administration & dosage / Q000097:blood*; D012015:Reference Standards
D002316:Cardiotonic Agents; D010879:Piperazines; D011728:Pyridones; C058572:saterinone