title: Determination of mycophenolic acid in human plasma by high-performance liquid chromatography.
abstract: The development, validation and evaluation of high-performance liquid chromatography (HPLC) method for quantifying mycophenolic acid in human plasma is described. The method involved protein precipitation using acetonitrile, after addition of terazosin as an internal standard. Separation was achieved with a reversed-phase C18 column (250 mm x 4.6 mm) employing UV detection at 215 nm. The mobile phase consisted of 0.02 M potassium dihydrogenphosphate solution adjusted to pH 6.9 with 2 M potassium hydroxide solution-acetonitrile (80:20 (v/v)) at a flow rate of 1.5 ml/min. The total run time was 21.0 min. The assay was linear from 0.2 to 25 microg/ml with goodness of fit (r2) greater than 0.99 observed with three precision and accuracy batches during validation. The observed mean recoveries were 89.3 and 98.0% for drug and internal standard, respectively. The applicability of this method to pharmacokinetic studies was established after successful application during a 34-subject bioavailability study. The method was found to be precise, accurate and specific during the study.
authors.affiliation: Bioanalytical Department, Lambda Therapeutic Research Pvt. Ltd., 42 Premier House-1, Gandhinagar-Sarkhej Highway, Bodakdev, Ahmedabad 380 054, India. vsrivatsan@lambda-cro.com
authors.forename: V
authors.initials: V
authors.lastname: Srivatsan
authors.forename: A K
authors.initials: AK
authors.lastname: Dasgupta
authors.forename: Prashant
authors.initials: P
authors.lastname: Kale
authors.forename: Ravi
authors.initials: R
authors.lastname: Verma
authors.forename: Paresh
authors.initials: P
authors.lastname: Joshi
authors.forename: Devangi
authors.initials: D
authors.lastname: Soni
authors.forename: Mahendra
authors.initials: M
authors.lastname: Patel
authors.forename: Gunjan
authors.initials: G
authors.lastname: Soni
authors.forename: Jignesh
authors.initials: J
authors.lastname: Patel
authors.forename: Harshad
authors.initials: H
authors.lastname: Modi
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000097:blood*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D005615:Freezing; D006801:Humans; D007202:Indicators and Reagents; D009173:Mycophenolic Acid / Q000097:blood*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions
chemical_list: D000903:Antibiotics, Antineoplastic; D007202:Indicators and Reagents; D012996:Solutions; D009173:Mycophenolic Acid