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化学计量学模型在紫外可见光谱中的应用：在液体溶液连续流中同时测定 API 和关键赋形剂的方法开发。

Application of chemometric modelling to UV-Vis spectroscopy: development of simultaneous API and critical excipient assay in a liquid solution continuous flow.

机构信息

Product Supply Innovation, Global Technical Operations Manufacturing Technology & Science, Ferring International Center SA, St-Prex, Switzerland.

出版信息

Pharm Dev Technol. 2020 Oct;25(8):919-929. doi: 10.1080/10837450.2020.1770789. Epub 2020 Jun 4.

DOI:10.1080/10837450.2020.1770789
PMID:32496145
Abstract

By applying Chemometric modelling to UV-Vis spectroscopy, a single Multi-Variate Data Analysis predictive model, for in-line monitoring of two component concentrations in solution formulation, was developed. The purpose of this article is to summarize the experimental development work performed for the UV-Vis analytical method and calibration modelling to determine the content of active pharmaceutical ingredient Carbetocin and the content of one critical excipient (l-methionine) in PABAL® solution for injection 100 µg/mL.

摘要

应用化学计量学模型对紫外可见光谱进行分析，建立了一个多变量数据分析预测模型，用于在线监测溶液制剂中两种成分的浓度。本文的目的是总结为确定注射用 PABAL®100μg/ml 溶液中活性药物成分卡贝缩宫素和一种关键赋形剂（l-蛋氨酸）含量而进行的紫外可见分析方法和校准模型的实验开发工作。

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