Analytical and real‐time technology in pharmaceutical manufacturing process is an important need to ensure that manufactured drugs are safe and effective. Raman spectroscopy is an emerging technique that is able to perform quantitative analysis nondestructively due to the molecular structure of many drugs. Monitoring the content uniformity and quantification of active pharmaceutical ingredient (API) in the tablet preparation process, without the assistance of solvent, is one of the key concerns in the formulation design in order to provide stable, pure, and homogenous finished products. In this study, we investigated the possibility of using Raman data as an analytical method to quantify API, the intra‐ and inter‐sample uniformity of content in the tableting process of Metformin hydrochloride tablets (C4H11N5.HCl). Analysis of all standard samples for prediction of API uniformity represents an acceptable accuracy and precision with a relative standard deviation of 2.55%. Further investigation of tablets regarding to relative Raman intensity of some characteristic peaks demonstrates the amount of API content with an accuracy of ≥96%. These values have a good adaption with pharmacopeia monograph. Findings reveal that the Raman method can be routinely utilized for quantifying API, controlling the content uniformity and the stability of drugs in different stages of manufacturing.

中文翻译：

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通过研究盐酸二甲双胍压片工艺，拉曼光谱准确评估制药行业基本标准的可行性

药品生产过程中的分析和实时技术是确保生产的药品安全有效的重要需求。拉曼光谱是一种新兴技术，能够根据许多药物的分子结构进行无损定量分析。在不借助溶剂的情况下，在片剂制备过程中监测活性药物成分（API）的含量均匀性和定量是配方设计中的关键问题之一，以提供稳定、纯净和均质的成品。在本研究中，我们研究了使用拉曼数据作为分析方法来量化 API、盐酸二甲双胍片压片过程中样品内和样品间含量均匀性的可能性（C4H11氮5.HCl)。对用于预测 API 均匀性的所有标准样品进行的分析显示出可接受的准确度和精密度，相对标准偏差为 2.55%。进一步对片剂中某些特征峰的相对拉曼强度进行研究，表明 API 含量的准确度≥96%。这些值与药典各论有很好的适应性。研究结果表明，拉曼方法可常规用于API的定量、控制药物在不同生产阶段的含量均匀性和稳定性。