Bouveresse E, Casolino C, de la Pezuela C
Dipartimento di Analisi e Tecnologie Farmaceutiche ed Alimentari, Genova, Italy.
J Pharm Biomed Anal. 1998 Oct;18(1-2):35-42. doi: 10.1016/s0731-7085(98)00169-1.
Near infrared spectroscopy has become very popular in the pharmaceutical industry because of many important practical advantages. With the help of powerful chemometric techniques, multivariate calibration models are developed, relating near-infrared spectra to the values to be modelled. However, because of small instrumental differences between near-infrared spectrometers, a calibration model can only be used with spectra collected on the same instrument, which represents a serious limitation for the use of near-infrared spectroscopy in the pharmaceutical industry. To deal with this important problem, a certain number of different standardisation approaches were proposed in the literature. In this article, an application of instrument standardisation methods is presented, where two different data measurement modules (internal measurement cell and external fibre optic module) of a near-infrared spectrometer must be standardised for the quantitative determination of an active compound in pharmaceutical tablets.
由于具有许多重要的实际优势，近红外光谱技术在制药行业变得非常流行。借助强大的化学计量学技术，开发了多变量校准模型，将近红外光谱与待建模的值联系起来。然而，由于近红外光谱仪之间存在微小的仪器差异，校准模型只能用于在同一台仪器上采集的光谱，这对近红外光谱技术在制药行业的应用来说是一个严重的限制。为了解决这个重要问题，文献中提出了一些不同的标准化方法。本文介绍了仪器标准化方法的一种应用，其中近红外光谱仪的两个不同数据测量模块（内部测量池和外部光纤模块）必须进行标准化，以便对药片中的活性成分进行定量测定。
