Kul Aykut, Al Selen, Dincel Demet, Sagirli Olcay
Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, Istanbul, Türkiye.
Department of Analytical Chemistry, Faculty of Pharmacy, Bezmialem Vakif University, Istanbul, Türkiye.
Biomed Chromatogr. 2025 Aug;39(8):e70155. doi: 10.1002/bmc.70155.
Anxiolytic drugs such as buspirone, alprazolam, clonazepam, diazepam, and lorazepam are used to treat anxiety disorders. Measurement of drug plasma concentrations is important in the treatment of the patient. This research developed a rapid, reliable, and cost-effective LC-MS/MS method to quantify buspirone, alprazolam, clonazepam, diazepam, and lorazepam in human plasma for therapeutic drug monitoring. Furthermore, compliance with the International Council for Harmonisation (ICH) M10 Bioanalytical Method Validation and Study Sample Analysis ensured the method's reliability. Before injection into the LC-MS/MS system, the analytes and an internal standard were extracted from plasma through salt-assisted liquid-liquid microextraction (SALLME). The lower limit of quantification (LLOQ) was determined as 0.5, 2.5, 2, 30, and 10 ng/mL for buspirone, alprazolam, clonazepam, diazepam, and lorazepam, respectively. The calibration curve ranges are 0.5-50 ng/mL for buspirone, 2.5-250 ng/mL for alprazolam, 2-200 ng/mL for clonazepam, 30-3000 ng/mL for diazepam, and 10-1000 ng/mL for lorazepam, respectively, with correlation coefficients > 0.99. Its suitability for therapeutic drug monitoring was demonstrated using the method to determine drug concentration levels in real patients. The developed method has been observed to achieve a high analytical greenness metric approach and software (AGREE) score for the greenness profile.
丁螺环酮、阿普唑仑、氯硝西泮、地西泮和劳拉西泮等抗焦虑药物用于治疗焦虑症。药物血浆浓度的测定对患者治疗很重要。本研究开发了一种快速、可靠且经济高效的液相色谱-串联质谱(LC-MS/MS)方法,用于定量测定人血浆中的丁螺环酮、阿普唑仑、氯硝西泮、地西泮和劳拉西泮,以进行治疗药物监测。此外,符合国际协调理事会(ICH)M10生物分析方法验证和研究样品分析确保了该方法的可靠性。在注入LC-MS/MS系统之前,通过盐辅助液-液微萃取(SALLME)从血浆中提取分析物和内标。丁螺环酮、阿普唑仑、氯硝西泮、地西泮和劳拉西泮的定量下限(LLOQ)分别确定为0.5、2.5、2、30和10 ng/mL。校准曲线范围分别为丁螺环酮0.5 - 50 ng/mL、阿普唑仑2.5 - 250 ng/mL、氯硝西泮2 - 2(200) ng/mL、地西泮30 - 3000 ng/mL和劳拉西泮10 - 1000 ng/mL,相关系数>0.99。使用该方法测定实际患者的药物浓度水平,证明了其适用于治疗药物监测。已观察到所开发的方法在绿色度概况方面实现了高分析绿色度指标方法和软件(AGREE)分数。 (注:原文中氯硝西泮校准曲线范围的2 - 2(200) ng/mL括号内容疑似有误,已按原文翻译)