Development and validation of an HPLC method for determination of carbamazepine in human plasma and applications to a therapeutic drug monitoring study

Yıl 2020, Cilt: 50 Sayı: 1, 6 - 15, 01.04.2020

Emrah Dural Süleyman Çetin Aslı Bolayır Burhanettin Çiğdem

Öz

Background and Aims: Carbamazepine (CBZ) is an antiepileptic drug, which is prescribed as a first-line drug for the treatment of partial and generalized tonic–clonic epileptic seizures. The aim of this study was to develop and validate a simple, fast and reliable HPLC method for the determination of carbamazepine in human plasma. Methods: Chlorpromazine (CPR) was used as an internal standard. The separation was conducted with a C18 reverse-phase column (150x3.9 mm, 5 µm) at 30°C, using a mobile phase prepared with 20 mM KH2PO4, acetonitrile and methanol (6:3:1, v/v/v) by isocratic elution. Results: The method was linear between 0.5 and 40 µg/mL, determined by 10 individual calibration points. Total run time was ≤ 5 mins. Accuracy (RE%) values were determined between (-5.6) and 3.6%, and precision was determined at ≤4.2%. Limit of detection (LOD) was 0.04 µg/mL. The robustness test results of the method showed good values. Plasma CBZ of (n=30) those receiving CBZ quantities ranging from 0.2 to 1.2 g/day were measured with this method, and following analyses of their concentrations were found to be between 0.1 and 11.4 µg/mL (6.2±2.4 µg/mL). While all plasma sample analyses were applied properly, it was observed that 16 (53.3%) of the plasma samples had CBZ lower than the recommended range. In addition to that, female patient plasma-CBZ levels were found significantly higher than male plasma contents (p<0.05). Conclusion: This method was found suitable for the analysis of plasma samples collected during the therapeutic drug monitoring (TDM) of patients treated with CBZ.

Anahtar Kelimeler

Carbamazepine, plasma, therapeutic drug monitoring, high-performance liquid chromatography, ultraviolet detection

Kaynakça

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