Contact an Account ManagerParent drug and/or metabolite? Which of them is most appropriate to establish bioequivalence of two oral oxcarbazepine formulations in healthy volunteers?
Summary
Type: HPLC
Application #: 122320
Detection: Blood samples (10 ml) from a suitable antecubital vein were collected into sodic heparin (20 µl) after the administration of oxcarbazepine formulation. Samples were centrifuged (4000 rpm, 10 min, RT). Plasma was separated and equal volumes were placed in tubes and stored at -20 °C for oxcarbazepine and its metabolite assessment.
Before an HPLC determination the plasma sample was defrosted (RT) and centrifuged (1400 g, 15 min). 500 µl of sample, 50 µl of internal standard (carbamazepine, 12 µg/ml), 500 µl of 1 M phosphate buffer (pH 7.4) and 6 ml dichloromethane were shaken (15 min) and centrifuged (1000 g, 15 min). 3 ml of organic phase were taken, dried and the residue reconstituted with 200 µl of the mobile HPLC phase.
Conditions:
Eluent: water / methanol (45:55)
Flow rate: 1.1 ml/min
Injection volume: 50 µl
Authors: Di Girolamo, G.; Opezzo, J.; Schere, D.; Gonzalez, C.; Moncalvo, J.
Source: Expert Opin. Pharmacother. (2007) 8(10), 1415-1423