测定药物剂型中托拉塞米的绿色高效液相色谱法:开发、验证和绿色评估

IF 1.3 4区 化学 Q3 CHEMISTRY, MULTIDISCIPLINARY Bulletin of the Chemical Society of Ethiopia Pub Date : 2023-11-29 DOI:10.4314/bcse.v38i1.2
Erten Akbel, I. Bulduk, Süleyman Gökçe
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引用次数: 0

摘要

为测定药品中的托拉塞米,我们开发了两种高效液相色谱法。第一种方法采用 C18 色谱柱,色谱柱温度恒定在 25 °C。流动相为 0.1% 甲酸水溶液和乙腈(体积比为 50/50),以 1.0 mL/min-1 的流速进行等度洗脱。使用紫外检测器在 288 纳米波长下进行检测。虽然所有其他条件都与第一种方法相同,但第二种方法的唯一不同之处在于流动相中使用了乙醇而非乙腈作为有机改性剂。高效液相色谱法根据 ICH 指南进行了验证。在 5-30 mg mL-1 的浓度范围内,相关系数大于 0.999。随后,HPLC 方法被应用于药物制剂。结果比较采用了学生(t)检验(均值)和费舍尔(F)检验(标准偏差)。不同方法之间未发现明显差异。此外,还使用 AGREE 软件对所开发的方法进行了绿色评估。结果表明,后一种方法被认为是测定药物中托拉塞米的最佳环保替代方法。 关键词: 绿色 HPLC 分析方法 托拉塞米 药品 Bull.Chem.Soc.2024, 38(1), 11-25.DOI: https://dx.doi.org/10.4314/bcse.v38i1.2
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A green HPLC method for the determination of torasemide in pharmaceutical dosage forms: Development, validation, and greenness assessment
Two HPLC methods were developed for the determination of torasemide in pharmaceutical products. In the first method, a C18 column whose temperature was kept constant at 25 °C was used. A combination of 0.1% formic acid solution in water and acetonitrile (50/50, v/v) was used as the mobile phase, and isocratic elution was performed at a flow rate of 1.0 mL min-1. Detection was carried out at 288 nm using the UV detector. Although all other conditions are the same as in the first method, the only difference in the second method is that ethanol is used instead of acetonitrile as the organic modifier in the mobile phase. HPLC methods were validated in accordance with ICH guidelines. Correlation coefficients were greater than 0.999 in the concentration range of 5-30 mg mL-1. Later, HPLC methods were applied to pharmaceutical formulations. Results were compared using the student (t) test for means and the Fischer (F) test for standard deviations. No significant differences were observed between methods. Additionally, a greenness evaluation of the developed methods was carried out using AGREE software. As a result, the latter method was proposed as an excellent eco-friendly alternative for the determination of torasemide in pharmaceuticals. KEY WORDS: Green HPLC, Analytical method, Torasemide, Pharmaceuticals   Bull. Chem. Soc. Ethiop. 2024, 38(1), 11-25. DOI: https://dx.doi.org/10.4314/bcse.v38i1.2
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来源期刊
CiteScore
2.20
自引率
8.30%
发文量
113
审稿时长
6-12 weeks
期刊介绍: The Bulletin of the Chemical Society of Ethiopia (BCSE) is a triannual publication of the Chemical Society of Ethiopia. The BCSE is an open access and peer reviewed journal. The BCSE invites contributions in any field of basic and applied chemistry.
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