打破药物分析中的障碍:简化液体制剂中氟哌啶醇和苯甲酸甲酯的紫外光谱定量和稳定性分析。

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2024-07-30 DOI:10.1016/j.ab.2024.115632
Khadidja Djilali , Rachida Maachi , Zohra Ait Mesbah , Nourddine Nasrallah , Nabil Touzout , Hichem Tahraoui , Jie Zhang , Abdeltif Amrane
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引用次数: 0

摘要

本研究旨在采用紫外光谱法和同时方程法对液体药物制剂(2 毫克/毫升)中的氟哌啶醇和苯甲酸甲酯进行定量。此外,我们还探讨了氟哌啶醇在各种应力条件下的稳定性。以 1%(v/v)乳酸溶液为溶剂,紫外分析显示氟哌啶醇在 248 纳米处有最大吸收峰,甲基苯甲酸酯在 256 纳米处有最大吸收峰。根据 ICH 指南进行的方法验证确认了该方法的可靠性,在线性、精密度、准确度和灵敏度方面均显示出优异的结果。该方法可直接应用于成品,无需提取即可同时定量。该方法简便、快速、成本效益高,是制药行业氟哌啶醇溶液分析中常规控制的理想方法。该方法还可用于监测强制降解,显示酸性和碱性条件下的光解和水解降解,同时确认热稳定性和氧化稳定性。这种拟议的紫外光谱法是药典推荐技术的有力替代品,简化了同时测定活性成分和防腐剂的过程。这简化了分析过程,减少了时间和成本。此外,这种方法对于缺乏精密仪器的小型企业来说也很有价值,可以深入了解活性成分在强制降解过程中的行为。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Breaking barriers in pharmaceutical analysis: Streamlined UV spectrometric quantification and stability profiling of haloperidol and methylparaben in liquid formulations

This study aims to quantify haloperidol and methylparaben in a liquid pharmaceutical formulation (2 mg/ml) using UV spectrometry and the simultaneous equations method. Additionally, we explored the stability of haloperidol under various stress conditions. The UV analysis revealed maximum absorption peaks at 248 nm for haloperidol and 256 nm for methylparaben, using a 1 % (v/v) lactic acid solution as the solvent. Method validation, conducted according to ICH guidelines, affirmed the method's reliability, showing excellent results in terms of linearity, precision, accuracy, and sensitivity. The method allows direct application to finished products, enabling simultaneous quantification without extractions. Its simplicity, speed, and cost-effectiveness make it ideal for routine controls in pharmaceutical industry haloperidol solution analyses. The method extends to monitoring forced degradation, indicating photolytic and hydrolytic degradation under acidic and basic conditions, while affirming thermal and oxidative stability. This proposed UV spectrometric method serves as a compelling alternative to pharmacopeia-recommended techniques, simplifying simultaneous determination of the active ingredient and preservative. This streamlines analysis, reducing time and costs. Additionally, it proves valuable in small industries lacking sophisticated instrumentation, offering insights into active ingredient behavior during forced degradation.

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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
自引率
2.10%
发文量
464
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