绿色高效液相色谱法测定药品中阿哌沙班的含量:建立与验证

IF 3.6 3区 化学 Q2 CHEMISTRY, ANALYTICAL Reviews in Analytical Chemistry Pub Date : 2023-01-01 DOI:10.1515/revac-2023-0058
Erten Akbel, I. Bulduk, Süleyman Gökçe
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引用次数: 0

摘要

阿哌沙班(apxaban, APX)是一种用于治疗缺血性脑卒中和静脉血栓栓塞的新型抗凝药物。本文建立了两种不同的色谱法测定药品中APX的方法。第一种方法采用Agilent C18色谱柱(250 mm × 4.6 mm, 5 μm),温度为30℃。流动相为0.1%三氟乙酸溶液-乙腈(65:35,v/v),等密度洗脱。流动相流速为1.0 mL·min−1,进样量为20µL。用紫外检测器在276 nm波长下进行检测。在第二种方法中,乙醇作为有机改性剂。这些方法之间的唯一区别是有机改性剂。所有方法的其他条件相同。根据ICH指南对两种色谱方法进行了各种参数的验证,如选择性、线性、准确度、精密度、检测和定量限以及鲁棒性。在APX 5 ~ 30 mg·mL−1的浓度范围内,色谱法测定系数均大于0.999,可用于片剂配方的分析。所得结果的均值比较采用Student’s (t)检验,标准差比较采用Fisher (F)检验。结果表明,两种方法间无显著性差异。然后使用AGREE-Analytical绿色度量软件对这两种方法进行评估。以乙醇为有机改性剂的色谱法是测定制剂中APX的一种环境友好、分析人员友好的方法。图形抽象
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A green HPLC method for the determination of apixaban in pharmaceutical products: Development and validation
Abstract Apixaban (APX) is a novel anticoagulant drug used in the treatment of ischemic stroke and venous thromboembolism. In this study, two different chromatographic methods were developed for the determination of APX in pharmaceutical products. In the first method, an Agilent C18 column (250 mm × 4.6 mm, 5 μm) was used, and the temperature was kept constant at 30°C. The mobile phase was chosen to be 0.1% trifluoroacetic acid solution and acetonitrile (65:35, v/v), and isocratic elution was applied. The flow rate of the mobile phase was found to be 1.0 mL·min−1 and the injection volume was 20 µL. The detection was carried out at a wavelength of 276 nm using a UV detector. In the second method, ethanol was used as an organic modifier. The only difference between these methods was the organic modifier. All other conditions of the methods were the same. Both chromatographic methods were validated in accordance with ICH guidelines for various parameters such as selectivity, linearity, accuracy, precision, detection and quantification limit, and robustness. The determination coefficients of chromatographic methods were greater than 0.999 in the concentration range of 5–30 mg·mL−1 of APX. Later, these chromatographic methods were applied to tablet formulations. Comparison of the obtained results in terms of mean was made using Student’s (t) test, and comparisons in terms of standard deviations were made using the Fisher (F) test. It was observed that there was no significant difference between these methods. These two methods were then evaluated using AGREE-Analytical greenness metric software. The chromatographic method using ethanol as an organic modifier has been proposed as an excellent eco-friendly and analyst-friendly alternative for the determination of APX in pharmaceutical formulations. Graphical abstract
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来源期刊
Reviews in Analytical Chemistry
Reviews in Analytical Chemistry 化学-分析化学
CiteScore
7.50
自引率
0.00%
发文量
15
审稿时长
>12 weeks
期刊介绍: Reviews in Analytical Chemistry publishes authoritative reviews by leading experts in the dynamic field of chemical analysis. The subjects can encompass all branches of modern analytical chemistry such as spectroscopy, chromatography, mass spectrometry, electrochemistry and trace analysis and their applications to areas such as environmental control, pharmaceutical industry, automation and other relevant areas. Review articles bring the expert up to date in a concise manner and provide researchers an overview of new techniques and methods.
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