Quantification of oxcarbazeipine and its active metabolite 10-hydroxycarbazepine in human plasma by high-performance liquid chromatography.
A simple, sensitive and selective high-performance liquid chromatography (HPLC) method with ultraviolet detection (230 nm) was developed and validated for the quantification of oxcarbazepine (CAS 28721-07-5), a new antiepileptic drug, and its active metabolite 10-hydroxycarbazepine (CAS 29331-92-8) in human plasma. Following solid-phase extraction, the analytes and internal standard (zaleplon, CAS 151319-34-5) were separated using an isocratic mobile phase on a reverse phase C18 column. The lower limit of quantification was 50 ng/mL for oxcarbazepine and 100 ng/mL for 10-hydroxycarbazepine with a relative standard deviation of less than 10%. A linear dynamic range of 50 to 5000 ng/mL for oxcarbazepine and of 100 to 10000 ng/mL for 10-hydroxycarbazepine was established. This HPLC method was validated with between-batch precision of 0.8 to 8.6% and 3.2 to 7.5% for oxcarbazepine and 10-hydroxycarbazepine respectively. The between-batch accuracy was 94.0 to 102.4% and 95.4 to 105.6%, respectively. Stability of oxcarbazepine and 10-hydroxycarbazepine in plasma was excellent, with no evidence of degradation during sample processing (autosampler) and 30 days storage in a freezer. This validated method is sensitive, simple and repeatable enough to be used in pharmacokinetic studies.
Nirogi
Ramakrishna V S
RV
Biopharmaceutical Research, Suven Life Sciences Ltd., Hyderabad, India. ramakrishna_nirogi@yahoo.co.in
Kandikere
Vishwottam N
VN
Shukla
Manoj
M
Mudigonda
Koteshwara
K
Ajjala
Devender R
DR
D000927:Anticonvulsants / Q000097:blood* / Q000493:pharmacokinetics; D002138:Calibration; D002220:Carbamazepine / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D000078330:Oxcarbazepine; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013810:Therapeutic Equivalency
C039775:10,11-dihydro-10-hydroxycarbamazepine; D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine