Environmental sustainability profiles assessment of HPLC stability indicating method for quantitation of piracetam and vincamine in pharmaceutical medications

IF 3.7 Q1 CHEMISTRY, ANALYTICAL Talanta Open Pub Date : 2025-08-01 Epub Date: 2025-01-18 DOI:10.1016/j.talo.2025.100407

Samya Sh. Alenezi , Ayman A. Gouda , Ragaa El Sheikh , Niaf A. Badahdah , Muneer E Alzuhiri , Ali H. Magrabi , Asim L. Jilani , Ahmed S. Darwish

{"title":"Environmental sustainability profiles assessment of HPLC stability indicating method for quantitation of piracetam and vincamine in pharmaceutical medications","authors":"Samya Sh. Alenezi , Ayman A. Gouda , Ragaa El Sheikh , Niaf A. Badahdah , Muneer E Alzuhiri , Ali H. Magrabi , Asim L. Jilani , Ahmed S. Darwish","doi":"10.1016/j.talo.2025.100407","DOIUrl":null,"url":null,"abstract":"<div><div>Recently, significant focus has been placed on the development of suitable stability-indicating studies in pharmaceutical analysis. A comprehensive eco-friendly stability-indicating RP-HPLC method has been developed and validated for the determination of piracetam and vincamine in hard gelatin capsule dosage forms. Both components were subjected to various stresses, following the International Conference on Harmonization (ICH) guidelines. Piracetam, vincamine, and their breakdown products were successfully separated using the isocratic elution technique, and both medicinal compounds' quantification was carried out on the Kromasil C<sub>18</sub> column at room temperature. The mobile phase consists of 0.05 M potassium dihydrogen phosphate buffer pH 3.5:ethanol absolute (60:40, by volume), at a flow rate of 1.0 ml/min. Detection was implemented at 220 nm, considering the concentration levels of 80–550 and 4.0–28 μg/ml for piracetam and vincamine, respectively. The total analysis time was <5 min, establishing this mentioned chromatographic method as proper for regular quality control evaluations of both medications. The inclusion of ethanol absolute was required in order to obtain a sufficient resolution. Three methods were used to assess the environmental impact: Complementary modified green Analytical Procedure Index (ComplexMoGAPI), the eco-scale calculator, and the Analytical GREEnness metric (AGREE). The chromatographic method's eco-friendly is demonstrated by its final Eco-scale score of 76.5, AGREE score of 0.66, ComplexMoGAPI E-factor was 42 with five green segments, BAGI score of 82.5, and finally whiteness score of 97.5. Obviously, the simultaneous method is accurate, precise, ecofriendly, specific, robust, and rugged. Finally, it can be used successfully for regular quality control analysis of piracetam and vincamine in both their pure form and hard gelatin capsule dosage forms.</div></div>","PeriodicalId":436,"journal":{"name":"Talanta Open","volume":"11 ","pages":"Article 100407"},"PeriodicalIF":3.7000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Talanta Open","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666831925000104","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/18 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}

引用次数: 0

Abstract

Recently, significant focus has been placed on the development of suitable stability-indicating studies in pharmaceutical analysis. A comprehensive eco-friendly stability-indicating RP-HPLC method has been developed and validated for the determination of piracetam and vincamine in hard gelatin capsule dosage forms. Both components were subjected to various stresses, following the International Conference on Harmonization (ICH) guidelines. Piracetam, vincamine, and their breakdown products were successfully separated using the isocratic elution technique, and both medicinal compounds' quantification was carried out on the Kromasil C₁₈ column at room temperature. The mobile phase consists of 0.05 M potassium dihydrogen phosphate buffer pH 3.5:ethanol absolute (60:40, by volume), at a flow rate of 1.0 ml/min. Detection was implemented at 220 nm, considering the concentration levels of 80–550 and 4.0–28 μg/ml for piracetam and vincamine, respectively. The total analysis time was <5 min, establishing this mentioned chromatographic method as proper for regular quality control evaluations of both medications. The inclusion of ethanol absolute was required in order to obtain a sufficient resolution. Three methods were used to assess the environmental impact: Complementary modified green Analytical Procedure Index (ComplexMoGAPI), the eco-scale calculator, and the Analytical GREEnness metric (AGREE). The chromatographic method's eco-friendly is demonstrated by its final Eco-scale score of 76.5, AGREE score of 0.66, ComplexMoGAPI E-factor was 42 with five green segments, BAGI score of 82.5, and finally whiteness score of 97.5. Obviously, the simultaneous method is accurate, precise, ecofriendly, specific, robust, and rugged. Finally, it can be used successfully for regular quality control analysis of piracetam and vincamine in both their pure form and hard gelatin capsule dosage forms.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

高效液相色谱法测定药物中吡拉西坦和长春胺含量的稳定性评价

近年来，人们把重点放在了药物分析中合适的稳定性指示研究的发展上。建立了一种生态友好的反相高效液相色谱法测定硬明胶胶囊剂型中吡拉西坦和长春胺的含量。根据国际协调会议（ICH）的指导方针，这两个组成部分都受到了各种压力。吡拉西坦、长春胺及其分解产物采用等容洗脱技术成功分离，两种药物化合物均在Kromasil C18色谱柱室温下进行定量。流动相为0.05 M磷酸二氢钾缓冲液，pH为3.5：无水乙醇（60:40，体积比），流速为1.0 ml/min。考虑吡拉西坦80 ~ 550 μg/ml和长春胺4.0 ~ 28 μg/ml的浓度水平，在220 nm下进行检测。总分析时间为5 min，建立了上述色谱法适用于两种药物的常规质量控制评价。为了获得足够的分辨率，必须加入无水乙醇。采用三种方法评估环境影响：互补修正绿色分析程序指数（ComplexMoGAPI）、生态尺度计算器和分析绿色度度量（AGREE）。最终Eco-scale得分为76.5，AGREE得分为0.66，ComplexMoGAPI e因子为42，有5个绿色区段，BAGI得分为82.5，最终白度得分为97.5，证明了色谱法的环保性。显然，该方法是准确的，精确的，环保的，专属性的，健壮的，坚固的。最后，该方法可用于吡拉西坦和长春胺纯剂型和硬明胶胶囊剂型的常规质量控制分析。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊