Ceska Slov Farm. 2022 Spring;71(2):67-77.
The aim of the present study is the development and validation of a simple method based on capillary zone electrophoresis coupled with UV detection for simultaneous determination of tramadol and paracetamol in pharmaceutical and biological samples. The background electrolyte was composed of 50 mM ammonium carbonate, which is a type of a non-conventional electrolyte system. The developed method was characterized by suitable validation parameters, such as linearity (coefficient of determination r2 0,995), selectivity or the limit of detection at the level of 0.25 - 0.5 μg/ml. Acceptable values of accuracy and precision were obtained, which were in good agreement with the recommended validation guidelines for analysis of pharmaceutical and biological samples. Detection was performed at a wavelength of 200 nm. The developed method was successfully applied to determine tramadol and paracetamol in various dosage forms and in urine biological samples. Achieved results indicate a potential of the method to be integrated in the common quality control processes of drugs and/or in bioanalysis.
本研究的目的是开发和验证一种基于毛细管区带电泳结合紫外检测的简单方法，用于同时测定药物和生物样品中的曲马多和扑热息痛。背景电解质由 50mM 碳酸铵组成，这是一种非常规的电解质体系。所开发的方法具有合适的验证参数，例如线性（决定系数 r2 为 0.995）、选择性或检测限为 0.25-0.5μg/ml。获得了可接受的准确度和精密度值，这与用于分析药物和生物样品的推荐验证指南一致。检测在 200nm 波长下进行。该方法成功地应用于各种剂型和尿液生物样品中曲马多和扑热息痛的测定。所得到的结果表明该方法有可能被整合到药物的常规质量控制过程中，或者被整合到生物分析中。
