Reaction Engineering Laboratory, Faculty of Mechanical and Process Engineering, Algiers, Algeria; University of Science and Technology Houari Boumediene, Algiers-Bab Ezzouar, Algeria.
Laboratory of Energy Processes and Nanotechnology, Blida, Algeria; Saad Dahlab University of Blida, Soumaa Street BP 270, BLIDA, Algeria.
Anal Biochem. 2024 Dec;695:115632. doi: 10.1016/j.ab.2024.115632. Epub 2024 Jul 30.
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.
本研究旨在使用紫外光谱法和联立方程法定量测定 2mg/ml 液体制剂中的氟哌啶醇和甲基对羟基苯甲酸。此外，我们还研究了氟哌啶醇在各种应激条件下的稳定性。紫外分析显示，氟哌啶醇在 248nm 处、甲基对羟基苯甲酸在 256nm 处有最大吸收峰，溶剂为 1%（v/v）乳酸溶液。根据 ICH 指南进行的方法验证证实了该方法的可靠性，在线性、精密度、准确度和灵敏度方面均表现出优异的结果。该方法可直接应用于成品，无需提取即可同时定量。其简单、快速且具有成本效益，非常适合制药行业中氟哌啶醇溶液的常规控制分析。该方法还可扩展用于监测强制降解，表明在酸性和碱性条件下的光解和水解降解，同时证实了热和氧化稳定性。与药典推荐的技术相比，所提出的紫外分光光度法是一种极具吸引力的替代方法，可简化对活性成分和防腐剂的同时测定。这简化了分析，减少了时间和成本。此外，对于缺乏复杂仪器的小型企业来说，它具有很高的价值，可深入了解活性成分在强制降解过程中的行为。
