Quantification of API content in pharmaceutical tablets within milliseconds by time-stretch near-infrared transmission spectroscopy

IF 3.1 3区医学 Q2 CHEMISTRY, ANALYTICAL Journal of pharmaceutical and biomedical analysis Pub Date : 2024-07-20 DOI:10.1016/j.jpba.2024.116372

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Abstract

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.

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用时间拉伸近红外透射光谱法在几毫秒内定量分析药片中的原料药含量

我们探索了利用近红外光谱对片剂产品中的活性药物成分（API）含量进行高速、高精度定量的可行性，以提高药品的可靠性。为此，我们采用了最近开发的高功率近红外时间拉伸透射光谱仪。通过使用该透射光谱仪和多元校准模型，我们证明了在短时间内（每片 3.9 毫秒）对模型药品的原料药含量进行定量的能力。对于模型片剂，我们的光谱仪的定量能力可与常用的傅立叶变换近红外（FT-NIR）光谱仪在数秒测量时间内实现的能力相媲美。我们还证实，用我们光谱仪使用的近红外脉冲照射药片的影响可以忽略不计。

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来源期刊

Journal of pharmaceutical and biomedical analysis 医学-分析化学

CiteScore

6.70

自引率

5.90%

发文量

588

审稿时长

37 days

期刊介绍： This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.