Analysis of pregabalin at therapeutic concentrations in human plasma/serum by reversed-phase HPLC.
A selective and sensitive HPLC method is described for assay of the new antiepileptic drug pregabalin in serum/plasma. Following acetone precipitation of the sample, the drug was derivatized with picryl sulfonic acid (PSA) before chromatography on a C8 column. No interference from coadministered antiepileptics has been observed. The assay is calibrated over the range 0.5 mg/L to 8 mg/L. In addition to qualitative and quantitative validation data for the assay, concentration measurements in predose samples from a group of patients with dose escalated to 600 mg/d pregabalin are presented. The drug concentrations measured were in the range 2.8-8.2 mg/L at steady state. The method is robust and will be suitable for monitoring pregabalin therapy.
Berry
David
D
Medical Toxicology Unit, Guy's and St Thomas' Trust, London, UK. david.berry@gstt.nhs.uk
Millington
Christopher
C
D000927:Anticonvulsants / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D002138:Calibration; D002220:Carbamazepine / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D004355:Drug Stability; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000097:blood / Q000188:drug therapy; D006801:Humans; D000077213:Lamotrigine; D000069583:Pregabalin; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D014227:Triazines / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D014302:Trinitrobenzenesulfonic Acid / Q000737:chemistry; D014635:Valproic Acid / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use
D000927:Anticonvulsants; D014227:Triazines; D002220:Carbamazepine; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D014635:Valproic Acid; D014302:Trinitrobenzenesulfonic Acid; D000077213:Lamotrigine