title: Quantitative determination of pravastatin and its metabolite 3α-hydroxy pravastatin in plasma and urine of pregnant patients by LC-MS/MS.
abstract: This report describes the development and validation of a chromatography/tandem mass spectrometry method for the quantitative determination of pravastatin and its metabolite (3α-hydroxy pravastatin) in plasma and urine of pregnant patients under treatment with pravastatin, as part of a clinical trial. The method includes a one-step sample preparation by liquid-liquid extraction. The extraction recovery of the analytes ranged between 93.8 and 99.5% in plasma. The lower limits of quantitation of the analytes in plasma samples were 0.106 ng/mL for pravastatin and 0.105 ng/mL for 3α-hydroxy pravastatin, while in urine samples they were 19.7 ng/mL for pravastatin and 2.00 ng/mL for 3α-hydroxy pravastatin. The relative deviation of this method was <10% for intra- and interday assays in plasma and urine samples, and the accuracy ranged between 97.2 and 106% in plasma, and between 98.2 and 105% in urine. The method described in this report was successfully utilized for determining the pharmacokinetics of pravastatin in pregnant patients enrolled in a pilot clinical trial for prevention of preeclampsia.
authors.affiliation: Maternal Fetal Pharmacology and Bio-development Laboratories, Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555-0587, USA.
authors.forename: Xing
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Maternal Fetal Pharmacology and Bio-development Laboratories, Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555-0587, USA.
authors.forename: Daria I
authors.initials: DI
authors.lastname: Vernikovskaya
authors.affiliation: Maternal Fetal Pharmacology and Bio-development Laboratories, Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555-0587, USA.
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Wang
authors.affiliation: Maternal Fetal Pharmacology and Bio-development Laboratories, Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555-0587, USA.
authors.forename: Tatiana N
authors.initials: TN
authors.lastname: Nanovskaya
authors.affiliation: Maternal Fetal Pharmacology and Bio-development Laboratories, Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555-0587, USA.
authors.forename: Maged
authors.initials: M
authors.lastname: Costantine
authors.affiliation: Maternal Fetal Pharmacology and Bio-development Laboratories, Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555-0587, USA.
authors.forename: Gary D V
authors.initials: GD
authors.lastname: Hankins
authors.affiliation: Maternal Fetal Pharmacology and Bio-development Laboratories, Department of Obstetrics and Gynecology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555-0587, USA.
authors.forename: Mahmoud S
authors.initials: MS
authors.lastname: Ahmed
mesh_terms: D000924:Anticholesteremic Agents / Q000097:blood* / Q000378:metabolism / Q000652:urine*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D005260:Female; D006801:Humans; D057230:Limit of Detection; D059625:Liquid-Liquid Extraction / Q000379:methods; D017035:Pravastatin / Q000097:blood* / Q000378:metabolism / Q000652:urine*; D011247:Pregnancy; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000924:Anticholesteremic Agents; D017035:Pravastatin
keywords: 3α-hydroxy pravastatin; LC-MS/MS; metabolite; pravastatin; preeclampsia