卡马西平不纯物HPLC/ UV分析

前言：Carbamazepine is a medication indicated for use in epilepsy, trigeminal neuralgia and bipolar disorder.1 This widely prescribed tricyclic anticonvulsant is administered orally in usual doses of 400–1200 mg/day and is available in several

commercial tablet, capsule and suspension forms.1 Due to its narrow therapeutic range, tight control and routine

monitoring of plasma carbamazepine concentrations are required to optimize treatment while preventing adverse

drug effects.1 Safe and effective therapy necessitates reliable and accurate methods for assessing all aspects of drug quality, including purity, strength and stability.

仪器：Accela UHPLC system

Thermo Scientific UV

结论：

A simple, accurate and robust quantitative HPLC/UV assay for carbamazepine purity assessment was developed.Separation and detection of carbamazepine and four of its related synthetic impurities was achieved within 22 minutes using the Accela 1250 UHPLC system, a Hypersil GOLD CN column and a simple water/acetonitrile gradient. The highly efficient and selective Hypersil GOLD CN column enhanced resolution between carbamazepine and impurity A, provided　sensitivity gains through improved peak shapes, and eliminated the need for ion-pairing agents. Trace levels of　impurities (0.05% of parent drug) were easily detected. Impurities at levels of 0.2% of carbamazepine werequantifiable with ≤2% RSD. This simple HPLC/UV assay meets USP criteria and ICH guidelines and provides a　powerful alternative to the HPLC-based procedures currently recommended by regulatory agencies for QA/QC of carbamazepine purity.