Eco-friendly RP-HPLC method for determination of diazepam in coated tablet

IF 1.1 4区化学 Q3 CHEMISTRY, MULTIDISCIPLINARY

Macedonian Journal of Chemistry and Chemical Engineering Pub Date : 2023-12-24 DOI:10.20450/mjcce.2023.2683

Marija Tomić, Marijana Božinovska, Nataša Anevska-Stojanovska, Jelena Lazova, R. Petkovska, L. Anastasova, N. Nakov

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引用次数: 0

Abstract

A new eco-friendly RP-HPLC method for determining diazepam in coated tablets was developed and validated. The separation was achieved on a Lichrosper® 100 RP-18 (250 mm × 4 mm, 5 µm particle size) using the isocratic elution mode with a mobile phase composed of a mixture of water (H2O) and ethanol (EtOH) in a 40:60 (v/v %) ratio and a flow rate of 1.0 mL/min. The injection volume was 10 μL, and the detection wavelength was set at 254 nm. The column temperature was maintained at 35 ºC. The method was validated according to the ICH guideline, emphasizing selectivity/specificity, linearity, sensitivity, accuracy, precision, and robustness. The analytical method greenness score and Eco-scale approach were used for the method’s greenness assessment. The method was applied to determine the assay of diazepam in coated tablets and the uniformity of dosage units by content uniformity. Applying the method proposed in this study in the pharmaceutical industry is considered environmentally sustainable. It would bring benefits in terms of a safer working environment and reduction of toxic waste formation without compromising the reliability of the analytical results.

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用环保型 RP-HPLC 方法测定包衣片剂中的地西泮

开发并验证了一种新型环保型 RP-HPLC 方法，用于测定包衣片剂中的地西泮。采用等度洗脱模式，以水（H2O）和乙醇（EtOH）的混合物为流动相，流速为1.0 mL/min，在Lichrosper® 100 RP-18（250 mm × 4 mm，粒径5 µm）上进行分离。进样量为 10 μL，检测波长为 254 nm。色谱柱温度保持在 35 ºC。该方法按照 ICH 指南进行了验证，强调了选择性/特异性、线性、灵敏度、准确度、精密度和稳健性。该方法的绿色性评估采用了分析方法绿色性评分和生态尺度法。应用该方法测定了包衣片中地西泮的含量，并通过含量均一性确定了剂量单位的均一性。在制药行业应用本研究提出的方法被认为是环境可持续的。它将带来更安全的工作环境和减少有毒废物的产生，同时又不影响分析结果的可靠性。

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来源期刊

Macedonian Journal of Chemistry and Chemical Engineering 化学-工程：化工

CiteScore

1.60

自引率

20.00%

发文量

审稿时长

>12 weeks

期刊介绍： Macedonian Journal of Chemistry and Chemical Engineering (Maced. J. Chem. Chem. Eng.) is an official publication of the Society of Chemists and Technologists of Macedonia. It is a not-for-profit open acess journal published twice a year. The journal publishes original scientific papers, short communications, reviews and educational papers from all fields of chemistry, chemical engineering, food technology, biotechnology and material sciences, metallurgy and related fields. The papers published in the Journal are summarized in Chemical Abstracts.