title: An LC-MS/MS method for the simultaneous determination of goserelin and testosterone in rat plasma for pharmacokinetic and pharmacodynamic studies.
abstract: A liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) method was developed, using testosterone-d3 as a surrogate analyte, for the simultaneous quantification of goserelin and testosterone in rat plasma. According to this method, the pharmacokinetic and pharmacodynamic data were obtained from a single plasma sample aliquot. The method involved the addition of alarelin as an internal standard (IS) for goserelin and testosterone-(13)C3 for testosterone or testosterone-d3. The conditions for the separation of these two compounds were achieved on a ZORBAX Eclipse Plus C18 column (Agilent, 2.1 × 50 mm, 1.8 μm, Stockport, UK) in a single chromatographic run at a flow rate of 400 μL/min. In order to minimize interferences of complex matrix, the extraction of plasma consisted of a protein precipitation step using methanol, followed by purification using an Oasis(®) HLB solid-phase extraction column. The method was validated in the concentration range of 0.01-30.0 ng/mL for goserelin and 0.05-30.0 ng/mL for testosterone-d3, respectively. The within- and between-run precisions were 1.7-9.2% and 2.1-6.9%, respectively. The within- and between-run accuracies were -1.8 to 5.3% and -4.9 to 4.0%, respectively. This accurate and highly specific assay provides a useful method to evaluate the pharmacokinetics and pharmacodynamics of goserelin in rats.
authors.affiliation: School of Pharmacy, Yantai University, 264005 Yantai, PR China.
authors.forename: Shu
authors.initials: S
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., 264003 Yantai, PR China; Laboratory of Drug Metabolism and Pharmacokinetics, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang 110016, PR China.
authors.forename: Jiangbin
authors.initials: J
authors.lastname: Han
authors.affiliation: State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., 264003 Yantai, PR China.
authors.forename: Guangyi
authors.initials: G
authors.lastname: Leng
authors.affiliation: Laboratory of Drug Metabolism and Pharmacokinetics, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang 110016, PR China.
authors.forename: Xin
authors.initials: X
authors.lastname: Di
authors.affiliation: State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., 264003 Yantai, PR China.
authors.forename: Chunjie
authors.initials: C
authors.lastname: Sha
authors.affiliation: School of Pharmacy, Yantai University, 264005 Yantai, PR China; State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., 264003 Yantai, PR China.
authors.forename: Xuemei
authors.initials: X
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., 264003 Yantai, PR China.
authors.forename: Youxin
authors.initials: Y
authors.lastname: Li
authors.affiliation: School of Pharmacy, Yantai University, 264005 Yantai, PR China; State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., 264003 Yantai, PR China. Electronic address: wanhuiliu@ytu.edu.cn.
authors.forename: Wanhui
authors.initials: W
authors.lastname: Liu
mesh_terms: D000818:Animals; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D017273:Goserelin / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D016014:Linear Models; D008297:Male; D051381:Rats; D017207:Rats, Sprague-Dawley; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013739:Testosterone / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics
chemical_list: D017273:Goserelin; D013739:Testosterone
keywords: Goserelin; LC–MS/MS; Pharmacodynamic; Pharmacokinetic; Surrogate analyte; Testosterone