Production Division, Manufacturing Technology Department, Towa Pharmaceutical Co., Ltd., 3-8 Matsuo, Kadoma, Osaka 571-0044, Japan.
New Technology Development Department, R&D Division, Business Creation Division, USHIO INC., 6409 Motoishikawa, Aoba, Yokohama, Kanagawa 225-0004, Japan.
J Pharm Biomed Anal. 2024 Oct 15;249:116372. doi: 10.1016/j.jpba.2024.116372. Epub 2024 Jul 20.
We explored the feasibility of high-speed and high-accuracy quantification of active pharmaceutical ingredient (API) content in tablet products by near-infrared (NIR) spectroscopy to improve the reliability of pharmaceuticals. For this purpose, we employed a high-power NIR time-stretch transmission spectrometer recently developed by us. By using this transmission spectrometer with a multivariate calibration model, we demonstrated the ability to quantify API content with a short measurement time of 3.9 ms per tablet for model pharmaceuticals. For the model tablet, the quantification ability of our spectrometer was comparable to that achieved by a commonly used Fourier-transform NIR (FT-NIR) spectrometer with a measurement time of several seconds. We also confirmed that the effect of irradiating tablets with the NIR pulses used in our spectrometer was negligible.
我们探索了通过近红外（NIR）光谱法高速、高精度定量片剂产品中活性药物成分（API）含量的可行性，以提高药品的可靠性。为此，我们使用了我们最近开发的一种高功率 NIR 时频传输光谱仪。通过使用这种具有多元校准模型的传输光谱仪，我们证明了对模型药物进行 3.9ms 每片的短测量时间内定量 API 含量的能力。对于模型片剂，我们的光谱仪的定量能力与使用几秒钟测量时间的常用傅里叶变换近红外（FT-NIR）光谱仪相当。我们还证实了用我们的光谱仪中使用的 NIR 脉冲照射片剂的影响可以忽略不计。
