Validation of UV-Vis spectrophotometric colorimetric methods for Rifampicin quantification in PBS & biological matrices.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-14 DOI:10.1080/17576180.2025.2501942

Elma Ninta Br Ginting, Giovanni Valerio Lembang, Dian Arnita Putri Abdullah, Siti Sri Rejeki Nurrakhma, Muh Rayhan Iskandar Ridwan, Andi Dian Permana

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引用次数: 0

Abstract

Background: Rifampicin (RIF) is the main treatment for tuberculous meningitis (TBM), but its limited penetration across the blood-brain barrier significantly reduces its therapeutic efficacy. To address this limitation, smart-pH nanoparticles were designed to release RIF in inflamed area and incorperated into a thermosensitive in situ gel for enhanced drug delivery via the olfactory nerve.

Methods: UV-Vis spectrophotometry and colorimetric methods to quantify RIF in various media and biological matrices, including phosphate-buffered saline (PBS) at pH 7.4 and 5.0, plasma, and brain tissue. The main validation parameters assessed were selectivity, specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, extraction recovery, and dilution integrity.

Result: Method validation followed International Council for Harmonization (ICH) guidelines, demonstrating excellent linearity (r² = 0.999) and lower limit detection (LOD) of approximately 0,25-0.49 μg/mL were achieved in all media. The method demonstrated high accuracy (%RE -11.62% to 14.88%) and precision (%RSD 2.06% to 13.29%), meeting regulatory requirements.

Conclusion: This validated approach enables reliable RIF quantification in biological samples, supporting its application in in vitro release studies, ex vivo permeability studies, and in vivo pharmacokinetic evaluations. These findings contribute to the advancement of targeted drug delivery systems for TBM treatment.

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紫外-可见分光光度比色法在PBS和生物基质中定量利福平的验证。

背景：利福平（RIF）是结核性脑膜炎（TBM）的主要治疗药物，但其通过血脑屏障的渗透性有限，大大降低了其治疗效果。为了解决这一限制，研究人员设计了智能ph纳米颗粒，用于在炎症区域释放RIF，并将其结合到热敏原位凝胶中，以增强通过嗅觉神经的药物递送。方法：紫外可见分光光度法和比色法定量各种介质和生物基质中的RIF，包括pH为7.4和5.0的磷酸盐缓冲盐水（PBS）、血浆和脑组织。评估的主要验证参数为选择性、特异性、线性、检出限（LOD）、定量限（LOQ）、准确度、精密度、提取回收率和稀释完整性。结果：方法验证符合国际统一委员会（ICH）指南，线性良好（r2 = 0.999），在所有培养基中检测下限（LOD）约为0,25-0.49 μg/mL。方法准确度（%RSD -11.62% ~ 14.88%）和精密度（%RSD - 2.06% ~ 13.29%）符合标准要求。结论：该方法可实现生物样品中RIF的可靠定量，支持其在体外释放研究、体外渗透性研究和体内药代动力学评价中的应用。这些发现有助于TBM治疗的靶向药物输送系统的发展。

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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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.