通过磺酞染料衍生法测定培哚普利的四种生态友好型分光光度法:在片剂分析中的应用

IF 4.3 2区 化学 Q2 CHEMISTRY, MULTIDISCIPLINARY BMC Chemistry Pub Date : 2024-10-28 DOI:10.1186/s13065-024-01326-9
Liudmyla Halka, Tetyana Kucher, Marjan Piponski, Liubomyr Kryskiw, Nadiya Zarivna, Mariana Horyn, Nataliia Horlachuk, Khrystyna Duve, Liliya Logoyda
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引用次数: 0

摘要

如今,有必要扩大用于测定剂型中培哚普利的分光光度法库,以便进行简单、快速、"绿色 "和廉价的常规药物分析。在本研究中,采用了一种直接简单、"绿色 "和非萃取的分光光度法来定量检测片剂中的培哚普利,该方法基于离子对与磺胺染料形成的络合物。有色反应产物的吸光度在 405 纳米(溴甲酚绿,BCG)、397 纳米(溴甲酚紫,BCP 和溴百里酚蓝,BTB)和 598 纳米(溴酚蓝,BPB)处记录。为了获得最高的吸光度,通过对许多实验因素(如染料的最佳浓度和体积以及反应所消耗的时间)进行筛选,确定了最佳条件。在 0.44-3.96 µg/mL (BCG)、3.00-7.00 µg/mL (BCP)、4.00-12.00 µg/mL (BTB) 和 0.44-3.52 µg/mL (BPB)范围内,均符合比尔定律。所有四种方法都按照 ICH 指南进行了验证,确认了特异性和线性、准确性和精密度、检测限和定量限以及稳健性。这些经过验证的方法为片剂中培哚普利的定量分析提供了一种可靠的绿色方法,有助于制药分析中更安全、更可持续的实验室实践。
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Four ecofriendly spectrophotometric methods for the determination of perindopril through derivatization with sulphophtalein dyes: application to tablet analysis

Nowadays, there is a need to expand the bank of spectrophotometric methods for the determination of perindopril in dosage forms for the purposes of routine pharmaceutical analysis, which would be simple, express, «green» and inexpensive. In the present work, perindopril in tablets was quantified via a direct simple, «green», and non-extracting spectrophotometric approach based on the formation of ion-pair complexes with sulphophtalein dyes. The absorbances of the colored reaction products were registered at 405 nm (bromocresol green, BCG), 397 nm (bromocresol purple, BCP, and bromothymol blue, BTB) and 598 nm (bromophenol blue, BPB). To achieve the highest intensity of absorbance, optimum conditions were established by the screening of many experimental factors such as optimal concentration and volume of dyes, and the time consumed for the reaction. Beer’s law was obeyed in the ranges of 0.44–3.96 µg/mL (BCG), 3.00–7.00 µg/mL (BCP), 4.00–12.00 µg/mL (BTB) and 0.44–3.52 µg/mL (BPB). All four methods were validated in accordance with ICH guidelines, confirming specificity and linearity, accuracy and precision, limits of detection and quantification, robustness. These validated methods provide a reliable and green approach for the quantitative analysis of perindopril in tablets, contributing to safer and more sustainable laboratory practices in pharmaceutical analysis.

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来源期刊
BMC Chemistry
BMC Chemistry Chemistry-General Chemistry
CiteScore
5.30
自引率
2.20%
发文量
92
审稿时长
27 weeks
期刊介绍: BMC Chemistry, formerly known as Chemistry Central Journal, is now part of the BMC series journals family. Chemistry Central Journal has served the chemistry community as a trusted open access resource for more than 10 years – and we are delighted to announce the next step on its journey. In January 2019 the journal has been renamed BMC Chemistry and now strengthens the BMC series footprint in the physical sciences by publishing quality articles and by pushing the boundaries of open chemistry.
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