Repository logo
 

Development and validation of a sensitive and specific HPLC assay of cladribine for pharmacokinetics studies in rats

dc.contributor.authorYeung, P. K.en_US
dc.contributor.authorFerguson, C.en_US
dc.contributor.authorJarrar, A.en_US
dc.contributor.authorKing, B.en_US
dc.contributor.authorLi, M. L.en_US
dc.date.accessioned2013-09-24T15:00:34Z
dc.date.available2013-09-24T15:00:34Z
dc.date.issued2007en_US
dc.description.abstractPURPOSE: To develop and validate a sensitive and specific HPLC assay for cladribine (CdA) in plasma for pharmacokinetic studies in rats. METHODS: CdA and the internal standard AZT were purchased from Sigma-Aldrich Chem. The HPLC system consisted of a Shimadzu LC-9A pump, a 3 im, 250 x 2.0 mm I.D. high speed C18 column (Jupitertrade mark), preceded by a 5 im 4 4 mm I.D. C18 guard column (Licrocarttrade mark), an Agilent Model 1050 UV-VIS detector and a 3395 Integrator. The mobile phase was made up of 0.01M KH2PO4 (pH 5): methanol: acetonitrile 90:5:5). The system was operated at ambient temperature with a flow rate of 0.3 mL/min, and UV wavelength at 265 nm, and an operating pressure of ca. 1.56 kpsi. Extraction of cladribine and AZT from plasma was achieved by solid phase extraction using 100 mg/mL C18 SPE columns Extra-septrade mark). The assay was validated for sensitivity, precision, specificity and application for pharmacokinetic study in rats. RESULTS: Under these conditions, the average retention times of CdA and AZT were 13.5 and 21 min, respectively, and recoveries were between 80 - 95%. Standard curve constructed from plasma standards was linear from 0.1 ug/mL to 1 ug/mL with regression coefficient (r2) 0.99 or greater. Sensitivity assessed by on column injection was < 1 ng. Using a 50-uL plasma sample size, the mean intra assay variations 0.1 ug/mL were 7%, and inter assay variations over a period of 3 months for 5 separate batches were less than 20%. The assay was used to study a single dose pharmacokinetic study of CdA in rats after a 2 mg/kg subcutaneous injection. CONCLUSION: The described HPLC assay has adequate sensitivity and specificity to study pharmacokinetics of CdA in rats, and could be adapted also to clinical pharmacokinetic studies.en_US
dc.identifier.citationYeung, P. K., C. Ferguson, A. Jarrar, B. King, et al. 2007. "Development and validation of a sensitive and specific HPLC assay of cladribine for pharmacokinetics studies in rats." Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques 10(2): 231-236.en_US
dc.identifier.issn1482-1826en_US
dc.identifier.issue2en_US
dc.identifier.startpage231en_US
dc.identifier.urihttp://hdl.handle.net/10222/36665
dc.identifier.volume10en_US
dc.language.isoCheck Language Codeen_US
dc.relation.ispartofJournal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiquesen_US
dc.titleDevelopment and validation of a sensitive and specific HPLC assay of cladribine for pharmacokinetics studies in ratsen_US
dc.typeTexten_US

Files

Original bundle

Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
Yeung_Final.pdf
Size:
192.9 KB
Format:
Adobe Portable Document Format
Description:

Collections