环保高效液相色谱法同时测定泮托拉唑和多潘立酮的绿、白、蓝综合评价

IF 3.7 Q1 CHEMISTRY, ANALYTICAL
Aya Barseem , Reem H. Obaydo , Samar H. Elagamy
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引用次数: 0

摘要

建立了同时测定泮托拉唑(PAN)和多潘立酮(DOM)含量的环保反相高效液相色谱法。色谱分离采用CORTECS®Shield RP18色谱柱等密度洗脱,保持在25°C。流动相为乙醇和磷酸钾缓冲液(50.0 mM, pH 6.0),体积比为30:70,流速为1.0 mL/min,紫外检测波长为286 nm。PAN在1.0 ~ 25.0 μg/mL、DOM在3.0 ~ 30.0 μg/mL范围内呈良好的线性关系。它成功地应用于原料药和药物剂型的分析。使用分析生态尺度对所提出方法的绿色度进行了评估,得到总分83分,这表明对环境的影响最小。“白度”方法采用RGB 12模型进行评估,得到89.2分的高分,反映了分析性能、环境可持续性和实际实施的良好平衡。它的“蓝度”,代表实用性,是用BAGI工具测量的,得到了82.5分的总分。与先前报道的HPLC方法相比,该方法具有相当的实用性,同时通过使用乙醇作为有机改性剂而不是对环境有害的溶剂(如乙腈和甲醇),显示出更高的绿色。根据ICH Q2(R1)指南对该方法进行了充分验证,确认了其准确性、精密度、特异性和稳健性。此外,采用学生t检验和f检验对所提出的方法与先前报道的HPLC方法进行了统计比较。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Eco-friendly HPLC method for simultaneous determination of pantoprazole and domperidone: Comprehensive evaluation of greenness, whiteness, and blueness

Eco-friendly HPLC method for simultaneous determination of pantoprazole and domperidone: Comprehensive evaluation of greenness, whiteness, and blueness
An environmentally friendly RP-HPLC method was developed for the simultaneous determination of pantoprazole (PAN) and domperidone (DOM). Chromatographic separation was performed using isocratic elution on CORTECS® Shield RP18 column maintained at 25 °C. The mobile phase consisted of ethanol and potassium phosphate buffer (50.0 mM, pH 6.0) in a 30:70 (v/v) ratio, delivered at a flow rate of 1.0 mL/min, with UV detection at 286 nm. The method demonstrated excellent linearity within the concentration ranges of 1.0–25.0 μg/mL for PAN and 3.0–30.0 μg/mL for DOM. It was successfully applied to the analysis of both drugs in bulk and pharmaceutical dosage forms. The greenness of the proposed method was evaluated using the Analytical Eco-Scale, yielding a total score of 83, which indicates minimal environmental impact. The method "whiteness" was assessed using the RGB 12 model, resulting in a high total score of 89.2, reflecting a well-balanced combination of analytical performance, environmental sustainability, and practical implementation. Its "blueness," representing practical applicability, was measured using the BAGI tool and achieved a total score of 82.5. Compared to a previously reported HPLC method, the proposed method offers comparable practical applicability while exhibiting enhanced greenness through the use of ethanol as the organic modifier, rather than environmentally hazardous solvents such as acetonitrile and methanol. The method was fully validated according to ICH Q2(R1) guidelines, confirming its accuracy, precision, specificity, and robustness. Furthermore, the proposed method was statistically compared with a previously reported HPLC method using Student’s t-test and F-test.
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来源期刊
Talanta Open
Talanta Open Chemistry-Analytical Chemistry
CiteScore
5.20
自引率
0.00%
发文量
86
审稿时长
49 days
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