LifeLabs Medical Laboratories, Toronto, ON M9W6J6, Canada.
Laboratory of Analytical Chemistry, Department of Chemistry, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.
Molecules. 2021 Feb 5;26(4):824. doi: 10.3390/molecules26040824.
In the present research, a zone fluidics-based automated sensor for the analysis of captopril in in vitro dissolution samples is reported. Captopril is reacted under flow conditions with Ni(II) (10 mmol L) in alkaline medium (0.15% NH) to form a stable derivate, which is monitored spectrophotometrically at 340 nm. The chemical and instrumental parameters were carefully investigated and optimized. The validation of the developed method was performed in the range of 5 to 120% of the expected maximum concentration using the accuracy profiles as a graphical decision-making tool. The -expectation tolerance intervals did not exceed the acceptance criteria of ±10%, which means that 95% of future results will be encompassed in the defined bias limits. The variation of the relative bias ranged between -2.3% and 3.5% and the RSD values for repeatability and intermediate precision were lower than 2.3% in all cases. The limit of detection (LOD), and the lower and the upper limit of quantification (LLOQ, ULOQ) were satisfactory and found to be 1%, 5% and 120% (corresponding to 0.6, 2.78 and 66.67 μg mL in dissolution medium). The developed method was successfully applied for the analysis of captopril in dissolution tests of two commercially available batches.
在本研究中，报道了一种基于流区流体动力学的自动传感器，用于分析体外溶解样品中的卡托普利。卡托普利在流动条件下与 Ni(II)（10 mmol L）在碱性介质（0.15% NH）中反应，形成稳定的衍生物，然后在 340nm 处进行分光光度监测。仔细研究并优化了化学和仪器参数。使用准确度轮廓作为图形决策工具，在预期最大浓度的 5%至 120%范围内对开发方法进行了验证。-预期容忍区间不超过±10%的验收标准，这意味着 95%的未来结果将包含在定义的偏差范围内。相对偏差的变化范围在-2.3%至 3.5%之间，在所有情况下，重复性和中间精密度的 RSD 值均低于 2.3%。检测限（LOD）以及定量下限（LLOQ，ULOQ）令人满意，发现在溶解介质中分别为 1%、5%和 120%（对应于 0.6、2.78 和 66.67μg mL）。所开发的方法成功地应用于两种市售批次的卡托普利在溶解试验中的分析。
