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首页> 外文期刊>Applied Spectroscopy: Society for Applied Spectroscopy >Transmission Raman Spectroscopic Quantification of Active Pharmaceutical Ingredient in Coated Tablets of Hot-Melt Extruded Amorphous Solid Dispersion
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Transmission Raman Spectroscopic Quantification of Active Pharmaceutical Ingredient in Coated Tablets of Hot-Melt Extruded Amorphous Solid Dispersion

机译:热熔挤出无定形固体分散体涂覆片中活性药物成分的变速器拉曼光谱定量

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摘要

Transmission Raman spectroscopy is an emerging technique, capable of quantitative analysis of drug products nondestructively using a multivariate data analysis approach. We developed and validated a chemometric method to quantify the active pharmaceutical ingredient in coated tablets of hot-melt extruded amorphous solid dispersion. A partial least squares regression (PLSR) model was developed and validated based on transmission Raman spectra data collected from coated tablet samples with variations in the content of active pharmaceutical ingredient, excipients, water content, a key oxidative degradant, milled extrudate particle size distribution, and tablet hardness. The method was proven to be accurate, linear, specific, and robust. Our work demonstrates that transmission Raman spectroscopy (TRS) is a viable, cost-effective, secondary method to high-performance liquid chromatography (HPLC) for quantitation of active pharmaceutical ingredient (API) in coated tablets of hot-melt extruded amorphous solid dispersion.
机译:变速器拉曼光谱是一种新兴技术,能够使用多元数据分析方法无组织地对药品进行定量分析。我们开发并验证了一种化学计量方法,以量化热熔挤出无定形固体分散体的涂层片中的活性药物成分。基于从涂覆的片剂样品中收集的传输拉曼谱数据进行了局部最小二乘回归(PLSR)模型,其具有活性药物成分,赋形剂,含水量,粉状氧化降解,研磨的挤出物粒度分布的含量变化,和平板电脑硬度。该方法被证明是准确的,线性,特异性和强大的。我们的作品表明,传输拉曼光谱(TRS)是一种可行,经济效益,高性能的二次方法,用于高性能液相色谱(HPLC),用于定量热熔挤出无定形固体分散体的涂覆片中的活性药物成分(API)。

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