title: Analytical methods for the quantification of ibandronate in body fluids and bone.
abstract: The accurate determination of bisphosphonate levels in bone and biological fluids is important in both clinical and pharmacological/toxicological studies. Ibandronate is a potent nitrogen-containing bisphosphonate containing a tertiary amine group, which does not easily form chromophore derivatives that can be detected by UV light or fluorescence emissions. The current report describes the methodology and validation of a GC-MS assay for ibandronate in serum/plasma and urine, a similar, modified GC-MS method for measurement of bone ibandronate levels, and an ELISA for ibandronate determination in serum/plasma. The range of quantification for the GC-MS was 1-100 ng/ml and 2-7500 ng/ml in plasma or serum and urine, respectively, and 50-1600 pg/ml (potentially 10-320 pg/ml depending on sample size) for the ELISA in plasma or serum. These assays were comparable. The practical application of the assays in preclinical and clinical studies is briefly reviewed.
authors.affiliation: Roche Diagnostics GmbH, Pharma Research Penzberg, Germany.
authors.forename: Richard
authors.initials: R
authors.lastname: Endele
authors.forename: Heiner
authors.initials: H
authors.lastname: Loew
authors.forename: Frieder
authors.initials: F
authors.lastname: Bauss
mesh_terms: D000818:Animals; D001826:Body Fluids / Q000737:chemistry*; D001862:Bone Resorption; D004164:Diphosphonates / Q000032:analysis* / Q000097:blood / Q000652:urine; D004797:Enzyme-Linked Immunosorbent Assay; D008401:Gas Chromatography-Mass Spectrometry / Q000379:methods; D000077557:Ibandronic Acid; D051381:Rats; D012015:Reference Standards
chemical_list: D004164:Diphosphonates; D000077557:Ibandronic Acid