LC-MS/MS assay for the therapeutic drug monitoring of perampanel in children with drug-resistant epilepsy

• Autorzy: Dai Hao-Ran , Hu Ya-Hui , Long Jia-Yi , Xia Ying , Guo Hong-Li , Xu Jing , Ding Xuan-Sheng , Chen Jing , Lu Xiao-Peng , Chen Feng

Identyfikatory

DOI

10.1556/1326.2022.01023

• Języki publikacji: EN

Abstrakty

EN

Perampanel (PER) is the first clinically available selective antagonist of α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor approved globally for the treatment of epilepsy. Studies have recently underlined the significant association between dose-exposure-effect-adverse events of PER in patients with epilepsy, so the therapeutic drug monitoring (TDM) of PER is critical in clinical practices, especially for pediatric patients with drug-resistant epilepsy. Due to several limits in previous published analytical methods, herein, we describe the development and validation of a novel liquid chromatography tandem mass spectrometry (LC-MS/MS) method for monitoring PER in human plasma samples. Protein precipitation method by acetonitrile containing PER-d5 as internal standard was applied for the sample clean-up. Formic acid (FA, 0.2 mM) in both aqueous water and acetonitrile were used as the mobile phases and the analyte was separated by an isocratic elution. Qualification and quantification were performed under positive electrospray ionization (ESI) mode using the m/z 350.3 → 219.1 and 355.3 → 220.0 ions pairs transitions for PER and PER-d5, respectively. Potential co-medicated anti-seizure medications (ASMs) have no interference to the analysis. Calibration curves were linear in the concentration range of 1.00–2,000 ng mL⁻¹ for PER. The intra- and inter-batch precision, accuracy, recovery, dilution integrity, and stability of the method were all within the acceptable criteria and no matrix effect or carryover was found. This method was then successfully implemented on the TDM of PER in Chinese children with drug-resistant epilepsy. We firstly confirmed the apparent inter- and intra-individual PER concentration variabilities and potential drug-drug interactions between PER and several concomitant ASMs occurred in Chinese pediatric patients, which were also in line with previous studies in patients of other race.

Słowa kluczowe

EN

perampanel; LC-MS/MS; therapeutic drug monitoring; drug-resistant epilepsy; drug-drug interaction

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2023
• Tom: Vol. 35, no. 2
• Strony: 149--160
• Opis fizyczny: Bibliogr. 42 poz., rys., tab., wykr.

Twórcy

autor

Dai Hao-Ran

• Pharmaceutical Sciences Research Center, Department of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China
• School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, 210009, China

• https://orcid.org/0000-0002-2084-0862

autor

Hu Ya-Hui

• Pharmaceutical Sciences Research Center, Department of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China

autor

Long Jia-Yi

• Pharmaceutical Sciences Research Center, Department of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China
• School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, 210009, China

autor

Xia Ying

• Pharmaceutical Sciences Research Center, Department of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China

autor

Guo Hong-Li

• Pharmaceutical Sciences Research Center, Department of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China

autor

Xu Jing

• Pharmaceutical Sciences Research Center, Department of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China

autor

Ding Xuan-Sheng

• School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, 210009, China

autor

Chen Jing

• Department of Neurology, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China

autor

Lu Xiao-Peng

• Department of Neurology, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China

• https://orcid.org/0000-0001-9549-6982

autor

Chen Feng

• Pharmaceutical Sciences Research Center, Department of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, 210008, China

• https://orcid.org/0000-0003-4800-6762

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