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A Multivariate Control Chart Approach for Calibration Transfer between NIR Spectrometers for Simultaneous Determination of Rifampicin and Isoniazid in Pharmaceutical Formulation
Current Analytical Chemistry ( IF 1.8 ) Pub Date : 2018-09-03 , DOI: 10.2174/1573411014666171212141909
Eduardo Wagner Vasconcelos de Andrade 1 , Camilo de Lelis Medeiros de Morais 1 , Fernanda Saadna Lopes da Costa 1 , Kássio Michell Gomes de Lima 1
Affiliation  

Background Multivariate transfer techniques have become a widely accepted concept over the past few years, since they avoid full recalibration procedures when instruments are changed to analyze a specific sample. Objective This paper reports a multivariate control chart transfer approach between two near infrared (NIR) spectrometers for simultaneous determination of rifampicin and isoniazid in pharmaceutical formu-lation using Direct Standardization (DS). Method The control charts are based on the calculation of Net Analyte Signal (NAS) models and the transfer samples are selected by the Kennard-Stone (KS) algorithm. Three control charts (NAS, interfer-ence and residual) transferred on both the master and slave instruments were measured. Results As a result, a classification model for rifampicin and isoniazid developed on a primary instrument has been successfully transferred to a secondary instrument. The spectral differences after the standardiza-tion procedure were considerably reduced and errors values found in the charts for both analytes were comparable with the errors obtained for the original chart models. Conclusion The proposed approach appears to be a valid alternative to the commonly used transfer of multivariate calibration models in simultaneous determination of isoniazid and rifampicin in pharmaceuti-cal formulation.

中文翻译:

用于同时测定药物制剂中利福平和异烟肼的 NIR 光谱仪之间校准转移的多变量控制图方法

背景多变量传输技术在过去几年中已成为一个广泛接受的概念,因为当更换仪器以分析特定样品时,它们避免了完整的重新校准程序。目的 本文报道了一种在两台近红外 (NIR) 光谱仪之间使用直接标准化 (DS) 同时测定药物配方中的利福平和异烟肼的多变量控制图传输方法。方法 控制图基于净分析物信号 (NAS) 模型的计算,转移样本由 Kennard-Stone (KS) 算法选择。测量了在主从仪器上传输的三个控制图(NAS、干扰和残差)。结果 结果,在一级仪器上开发的利福平和异烟肼分类模型已成功转移到二级仪器上。标准化程序后的光谱差异显着减少,并且在图表中发现的两种分析物的误差值与原始图表模型获得的误差相当。结论 所提出的方法似乎是在同时测定药物制剂中的异烟肼和利福平中常用的多变量校准模型转移的有效替代方法。
更新日期:2018-09-03
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