Quality Control Laboratory, School of Pharmacy, Federal University of Goias, 74605-170, Goiânia - GO, Brazil.
J AOAC Int. 2023 Mar 1;106(2):309-315. doi: 10.1093/jaoacint/qsac142.
Tinidazole (TIN) has amoebicidal, giardicidal, antifungal, and antimicrobial activities. It is marketed in the form of tablets. Analytical methods to assess the quality of TIN-based products are essential for correct pharmacotherapy.
The objective of this review is to show an overview of the existing analytical methods for evaluating TIN, according to the quality control (QC) analysis routine and green analytical chemistry (GAC).
Official compendia show a method for evaluating TIN in tablets by nonaqueous titration, which has limitations (materials on the mg scale using solvents considered not recommended and harmful). The literature shows some analytical methods for evaluating TIN, both physicochemical and microbiological. The most used physicochemical method is UV (41%), and second is HPLC (28%). Among the microbiological methods, agar diffusion and turbidimetric methods are equally divided. The most studied matrix is TIN tablets (73%), and the most used solvent is methanol.
The literature shows space for the development of analytical methods according to GAC for evaluating TIN, optimizing time, resources, and materials, reducing waste generation, and opting for less aggressive reagents, solvents, and diluents.
This review shows the status of analytical methods, both physicochemical and microbiological, for the analysis of TIN in pharmaceutical matrix, in the context of routine analysis of the chemical-pharmaceutical industries and of GAC.
替硝唑(TIN)具有杀阿米巴虫、杀贾第鞭毛虫、抗真菌和抗菌活性。它以片剂形式上市。评估 TIN 产品质量的分析方法对于正确的药物治疗至关重要。
本综述旨在展示根据质量控制(QC)分析常规和绿色分析化学(GAC)评估 TIN 的现有分析方法概述。
官方药典显示了一种通过非水滴定法评估片剂中 TIN 的方法,但该方法存在局限性(使用被认为不推荐和有害的溶剂,在毫克级别的材料上)。文献中显示了一些评估 TIN 的分析方法,包括物理化学和微生物学方法。最常用的物理化学方法是紫外分光光度法(41%),其次是高效液相色谱法(28%)。在微生物学方法中,琼脂扩散法和比浊法平分秋色。研究最多的基质是 TIN 片剂(73%),最常用的溶剂是甲醇。
文献表明,根据 GAC 开发用于评估 TIN 的分析方法有空间,可以优化时间、资源和材料,减少废物生成,并选择更温和的试剂、溶剂和稀释剂。
本综述展示了 TIN 在药物基质中的分析的物理化学和微生物学分析方法的现状,涉及化学制药行业的常规分析和 GAC。