A green HPLC method for the determination of torasemide in pharmaceutical dosage forms: Development, validation, and greenness assessment

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2023-11-29 DOI:10.4314/bcse.v38i1.2

Erten Akbel, I. Bulduk, Süleyman Gökçe

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Abstract

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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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

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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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.