Bioxis Sdn. Bhd. PMT 1241, Jalan Perindustrian Bukit Minyak 8, Taman Perindustrian Bukit Minyak, Simpang Ampat 14100, Malaysia.
School of Chemical Sciences, Universiti Sains Malaysia, Minden 11800, Malaysia.
Molecules. 2022 Sep 4;27(17):5706. doi: 10.3390/molecules27175706.
Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The objective of the current study was to develop a sensitive, fast and high-throughput HPLC-ESI-MS/MS method to measure etoricoxib levels in human plasma using a one-step methanol protein precipitation technique. A tandem mass spectrometer equipped with an electrospray ionization (ESI) source operated in a positive mode and multiple reaction monitoring (MRM) were used for data collection. The quantitative MRM transition ions were m/z 359.15 > 279.10 and m/z 363.10 > 282.10 for etoricoxib and IS. The linear range was from 10.00 to 4000.39 ng/mL and the validation parameters were within the acceptance limits of the European Medicine Agency (EMA) and Food and Drug Analysis (FDA) guidelines. The present method was sensitive (10.00 ng/mL with S/N > 40), simple, selective (K prime > 2), and fast (short run time of 2 min), with negligible matrix effect and consistent recovery, suitable for high throughput analysis. The method was used to quantitate etoricoxib plasma concentrations in a bioequivalence study of two 120 mg etoricoxib formulations. Incurred sample reanalysis results further supported that the method was robust and reproducible.
依托考昔是一种非甾体抗炎药（NSAID），用于治疗疼痛和炎症。本研究的目的是开发一种灵敏、快速和高通量的 HPLC-ESI-MS/MS 方法，采用一步甲醇蛋白沉淀技术测定人血浆中的依托考昔水平。串联质谱仪配备电喷雾电离（ESI）源，以正模式和多反应监测（MRM）模式进行数据采集。定量 MRM 过渡离子为 m/z 359.15 > 279.10 和 m/z 363.10 > 282.10，用于依托考昔和 IS。线性范围为 10.00 至 4000.39ng/mL，验证参数符合欧洲药品管理局（EMA）和食品和药物分析（FDA）指南的接受标准。本方法灵敏（10.00ng/mL 时 S/N > 40）、简单、选择性好（K prime > 2）、快速（运行时间短至 2 分钟），基质效应可忽略且回收率一致，适用于高通量分析。该方法用于两种 120mg 依托考昔制剂生物等效性研究中的依托考昔血浆浓度定量。进一步的样品复测结果表明该方法稳健且重现性好。
