Near-infrared spectroscopy for the determination of testosterone in thin-film composites
Near-infrared spectroscopy for the determination of testosterone in thin-film composites
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DOI：
10.1016/s0731-7085(03)00345-5
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发表时间：
2003-09-19
影响因子：
3.4
通讯作者：
Mumper, RJ
中科院分区：
文献类型：
--
作者：
Fountain, W;Dumstorf, K;Mumper, RJ
在制药行业中，更快速、可重复和具有成本效益的方法来控制产品质量仍然是一个主要重点，特别是FDA通过其最近的过程分析技术（PAT）计划。已使用许多不同的方法来测定各种剂型药物的稳定性和含量均匀度;然而，这些方法中的大多数包括破坏样品。因此，开发允许分析每个单独剂型的非破坏性方法已成为许多研究的基础。建立了一种利用近红外光谱（NIR）无损测定粘膜粘附双层薄膜复合材料（TFCs）中睾酮含量的新方法。5组圆形膜（n = 5），理论睾酮含量为0、1、2、3和4 mg/3/8 in。在1100-2500 nm的近红外区域扫描直径的圆盘以测定睾酮含量。NIR结果直接与使用先前开发的睾酮紫外测定法在240 nm处获得的结果进行比较。进行主成分回归（PCR）以校准NIR测定。该相关性产生r（2）= 0.99，估计标准误差（SEE）= 0.18 mg，交叉验证的性能标准误差（SEP）= 0.18，样本数量相等（F检验通过，P = 0.05）。虽然UV测定法显示出稍好的r（2）值，但NIR测定法更快、更容易且无损。因此，近红外光谱分析可能具有显着的潜力，用于含药物的药物薄膜的质量控制。(C)2003 Elsevier B. V.保留所有权利。
More rapid, reproducible, and cost-effective methods to control product quality in the pharmaceutical industry continue to be a major emphasis, particularly with the FDA through its recent process analytical technologies (PAT) initiative. Many different methods have been used to determine the stability and content uniformity of a drug in various dosage forms; however, most of these methods include the destruction of the sample. Therefore, the development of nondestructive methods that allow the analysis of each individual dosage form has become the basis of much research. A new assay for the nondestructive determination of testosterone content in mucoadhesive bi-layer thin-film composites (TFCs) using near-infrared spectroscopy (NIR) was developed. Five sets of the circular films (n = 5) with theoretical testosterone content of 0, 1, 2, 3, and 4 mg per 3/8th in. diameter disks were scanned in the near-infrared region of 1100-2500 nm to determine testosterone content. The NIR results were directly compared with those obtained using a previously developed ultraviolet assay for testosterone at 240 nm. Principal component regression (PCR) was performed to calibrate the NIR assay. This correlation produced r(2) = 0.99 with a standard error of estimate (SEE) = 0.18 mg, and a standard error of performance (SEP) = 0.18 on cross validation with an equal number of samples (F test passed at P = 0.05). Though the UV assay showed a slightly better r(2) value, the NIR assay was much quicker, easier, and nondestructive. Therefore, the NIR assay may have significant potential for use in the quality control of pharmaceutical films containing drugs. (C) 2003 Elsevier B.V. All rights reserved.