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近红外光谱法与激光诱导击穿光谱法用于测定药用粉末和固体剂型中硬脂酸镁的比较。

Comparison of near-infrared and laser-induced breakdown spectroscopy for determination of magnesium stearate in pharmaceutical powders and solid dosage forms.

作者信息

Green Robert L, Mowery Mark D, Good Julie A, Higgins John P, Arrivo Steven M, McColough Kristen, Mateos Arthur, Reed Robert A

机构信息

Merck Research Laboratories, Pharmaceutical Research and Development, West Point, Pennsylvania 19486, USA.

出版信息

Appl Spectrosc. 2005 Mar;59(3):340-7. doi: 10.1366/0003702053585354.

DOI:10.1366/0003702053585354
PMID:15901316
Abstract

Near-infrared (NIR) spectroscopy has become well established in both the pharmaceutical arena and other areas as a useful technique for rapid quantitative analysis of solid materials. Though laser-induced breakdown spectroscopy (LIBS) has not been widely applied in the pharmaceutical industry, the technique has been used for rapid quantitative analysis of solids in many other applications. One analysis amenable to each technique is the determination of magnesium stearate in solids during the lubrication blending unit operation of pharmaceutical processing. A comparative study of the utility of these two techniques for this application will be presented. Necessary sample preparations and the extent and type of matrix effects will be discussed. Additionally, it will be shown that NIR provides better accuracy and precision than LIBS with the experimental parameters used; however, LIBS showed superior selectivity as it was demonstrated to be more robust to sample matrix perturbations. Examples of blending applications will also be presented.

摘要

近红外(NIR)光谱法在制药领域和其他领域已成为一种成熟的技术,用于对固体材料进行快速定量分析。虽然激光诱导击穿光谱法(LIBS)尚未在制药行业中广泛应用,但该技术已在许多其他应用中用于固体的快速定量分析。这两种技术都适用的一种分析方法是在药物加工的润滑混合单元操作过程中测定固体中的硬脂酸镁。将介绍这两种技术在此应用中的效用的比较研究。将讨论必要的样品制备以及基质效应的程度和类型。此外,结果表明,在所使用的实验参数下,近红外光谱法比激光诱导击穿光谱法具有更高的准确度和精密度;然而,激光诱导击穿光谱法表现出更好的选择性,因为它被证明对样品基质扰动更具稳健性。还将介绍混合应用的示例。

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引用本文的文献

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Challenges in detecting magnesium stearate distribution in tablets.检测片剂中硬脂酸镁分布的挑战。
AAPS PharmSciTech. 2013 Mar;14(1):435-44. doi: 10.1208/s12249-013-9927-3. Epub 2013 Feb 2.
2
Improvement of tablet coating uniformity using a quality by design approach.采用质量源于设计方法提高片剂包衣均匀度。
AAPS PharmSciTech. 2012 Mar;13(1):231-46. doi: 10.1208/s12249-011-9723-x. Epub 2012 Jan 10.