Assay of zatebradine in plasma by fully automated sample clean-up, capillary gas chromatography and ammonia chemical ionisation mass spectrometry.
A method has been developed for the measurement of zatebradine (UL-FS 49), a heart-rate lowering drug, suitable for the treatment of stable angina pectoris. The method comprises a fully automated liquid-solid extraction using a Zymark Benchmate, a capillary gas chromatography and ammonia chemical ionisation (CI) mass spectrometry using hexadeuterated zatebradine for the internal standard. The assay has a mean between-batch imprecision of 4.9% and a mean inaccuracy of 1.5%. The calibration curve covers the range of 1-30 ng/ml. About 60 samples can be handled per day. The assay has been successfully applied to human pharmacokinetic studies.
Department of Pharmacokinetics and Drug Metabolism, Dr. Karl Thomae GmbH, Biberach, Germany.
J
J
Schmid
A
A
Bücheler
B
B
Müller
D000641:Ammonia; D001322:Autoanalysis; D001552:Benzazepines / Q000097:blood* / Q000493:pharmacokinetics; D002138:Calibration; D002197:Capillary Action; D002317:Cardiovascular Agents / Q000097:blood* / Q000493:pharmacokinetics; D002849:Chromatography, Gas / Q000379:methods* / Q000706:statistics & numerical data; D003903:Deuterium; D004355:Drug Stability; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods* / Q000706:statistics & numerical data; D011786:Quality Control; D012680:Sensitivity and Specificity
D001552:Benzazepines; D002317:Cardiovascular Agents; D000641:Ammonia; D003903:Deuterium; C043636:zatebradine