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四种通过与磺酞染料衍生化测定培哚普利的环保型分光光度法:应用于片剂分析

Four ecofriendly spectrophotometric methods for the determination of perindopril through derivatization with sulphophtalein dyes: application to tablet analysis.

作者信息

Halka Liudmyla, Kucher Tetyana, Piponski Marjan, Kryskiw Liubomyr, Zarivna Nadiya, Horyn Mariana, Horlachuk Nataliia, Duve Khrystyna, Logoyda Liliya

机构信息

Department of Pharmaceutical Chemistry, I. Horbachevsky Ternopil National Medical University, Ternopil, Ukraine, Ruska 36, 46000.

Replek Farm Ltd, Skopje, North Macedonia, 1000.

出版信息

BMC Chem. 2024 Oct 28;18(1):209. doi: 10.1186/s13065-024-01326-9.

DOI:10.1186/s13065-024-01326-9
PMID:39468615
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11520074/
Abstract

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.

摘要

如今,出于常规药物分析的目的,需要扩展用于测定剂型中培哚普利的分光光度法的方法库,这些方法应简单、快速、“绿色”且廉价。在本工作中,基于与磺酞类染料形成离子对络合物,通过一种直接、简单、“绿色”且无需萃取的分光光度法对片剂中的培哚普利进行了定量。在405 nm(溴甲酚绿,BCG)、397 nm(溴甲酚紫,BCP和溴百里酚蓝,BTB)以及598 nm(溴酚蓝,BPB)处记录了有色反应产物的吸光度。为了获得最高吸光度强度,通过筛选许多实验因素(如染料的最佳浓度和体积以及反应所需时间)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)范围内符合比尔定律。所有四种方法均按照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且“绿色”的方法,有助于在药物分析中实现更安全、更可持续的实验室操作。

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