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一种新型的 RP-HPLC 方法用于测定大鼠血浆中新开发的替扎尼定和依托考昔组合:greens 评价的八项标准。

Novel RP-HPLC method for estimation of a newly developed combination of tizanidine and etoricoxib in rat plasma: Eight criteria for greens evaluation.

机构信息

Department of Chemistry, College of Science, Taibah University, Al-Madinah Al-Munawarah, Madinah, Saudi Arabia.

Chemistry Department, Faculty of Science at Yanbu, Taibah University, Yanbu, Saudi Arabia.

出版信息

Arch Pharm (Weinheim). 2024 Aug;357(8):e2400025. doi: 10.1002/ardp.202400025. Epub 2024 Apr 21.

DOI:10.1002/ardp.202400025
PMID:38644337
Abstract

A novel environmentally friendly reversed-phase high-performance liquid chromatography (RP-HPLC) method has been effectively validated for simultaneously measuring a prospective conjunction of tizanidine (TIZ) and etoricoxib (ETC), the combined medicine, in rat plasma. The technique employs diclofenac potassium as the internal standard, guaranteeing dependable and precise outcomes. This study aimed to assess the impact of the suggested combination therapy on treating inflammation resulting from rheumatoid arthritis (RA) in a rat model. The procedure was performed using an Agilent series 1200 model HPLC apparatus. The chromatographic conditions consist of isocratic elution mode, C18 column with dimensions of 150 mm × 4.6 mm × 5 µm, flow rate of 1.5 mL/min, wavelength of 230 nm, temperature of 50°C, and injection volume of 10 µL. The elution was performed using a mobile phase consisting of a phosphate buffer with a pH of 3.5 and acetonitrile in a ratio of 80:20 v/v. Calibration curves were conducted for TIZ and ETC within the 1-50 µg/mL range, demonstrating linear trends with R values over 0.999. The effectiveness and eco-friendliness of the proposed method were evaluated using eight separate environmentally conscious metrics. The addition of TIZ and ETC to arthritic rodents amplified these effects significantly. Furthermore, TIZ and ETC significantly reduced serum levels in arthritic rodents, and safety investigations revealed normal complete blood count, liver, and renal functions. TIZ and ETC appear to have antiarthritic, anti-inflammatory, and safe combinations, making them viable future treatment options for RA that are also safe and efficacious. Following validation by United States Food and Drug Administration (US-FDA) rules, all goods met the criteria.

摘要

一种新型环保反相高效液相色谱(RP-HPLC)法已被有效验证,可同时测量替扎尼定(TIZ)和依托考昔(ETC)的潜在结合物,即联合药物,在大鼠血浆中。该技术采用双氯芬酸钾作为内标,保证了可靠和精确的结果。本研究旨在评估该联合治疗方案对治疗类风湿关节炎(RA)大鼠模型炎症的影响。该方法使用安捷伦系列 1200 型 HPLC 仪器进行。色谱条件包括等度洗脱模式、150mm×4.6mm×5μm 的 C18 柱、流速 1.5ml/min、波长 230nm、温度 50°C 和 10μL 的进样体积。洗脱采用磷酸缓冲液(pH3.5)和乙腈(80:20v/v)的流动相进行。TIZ 和 ETC 的校准曲线在 1-50μg/ml 范围内进行,呈线性趋势,相关系数均大于 0.999。使用八项环保指标评估了所提议方法的有效性和环保性。在关节炎大鼠中加入 TIZ 和 ETC 显著增强了这些作用。此外,TIZ 和 ETC 显著降低了关节炎大鼠的血清水平,安全性研究显示全血细胞计数、肝功能和肾功能正常。TIZ 和 ETC 似乎具有抗关节炎、抗炎和安全的组合,使它们成为治疗 RA 的可行的未来治疗选择,同时也是安全有效的。所有产品均符合美国食品和药物管理局(US-FDA)的规定,经验证后均符合标准。

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