摘要
Abstract
Pharmacokinetic parameters of the cleviprex fat emulsion injection and origi-nal research products in beagle dogs plasma were identified by liquid chromatography-tandem mass spectrometry (LC-MS/MS).Taking amlodipine as internal standard, metabolites were separated on Phenomenex Luna C8(2.0 mm×150 mm×5 μm)column by the gradient elution with methanol-0.1% formic acid (82 ∶ 18,V/V )as mobile phase,and detected by positive ions electrospray ionization (ESI)mass spectrometry with fullscan-data dependent scan.Data was disposed through MassLynx4.1.The result shows that the linear range of cleviprex is 0.4-100 μg/L.The average values of C max ,T max ,T 1/2 ,AUC0→t and AUC0→∞ are (58.748 ± 1 6.738)μg/L,(2.938 ±0.678)μg/L,(1 1.88 ± 3.824 ) min,(1 883.821 ± 647.882 )μg · min/L,(1 889.834 ± 649.135)μg·min/L for the reference preparation,respectively.While the average val-ues of C max ,T max ,T 1/2 ,AUC0→t and AUC0→∞ are (53.706 ± 18.963)μg/L,(2.875 ± 0.991 )μg/L,(1 1.587±3.634)min,(1 856.541±590.653)μg·min/L,(1 863.485± 592.039)μg·min/L,for the test preparation,respectively.ANOVA and two one-sided t-tests analysis show that there is no significant difference with the pharmacokinetic parameters of the two formulations,and they have bioequivalent in Beagle dogs plasma.关键词
液相色谱-串联质谱(LC-MS/MS)/丁酸氯维地平/药代动力学/生物等效性Key words
liquid chromatography-tandem mass spectrometry (LC-MS/MS )/clev-iprex/pharmacokinetics/bioequivalence分类
化学化工
