DEVELOPMENT AND ASSESSMENT OF SPECTROSCOPY METHODOLOGIES AND CHEMOMETRICS STRATEGIES TO DETECT PHARMACEUTICALS BLEND ENDPOINT IN A PHARMACEUTICAL POWDER BLEND

Journal of The Chilean Chemical Society

article

César Pino-Torres¹  Rosario Castillo-Felices²  Rodolfo Mundaca-Uribe²  Paola Mendez-Herrera³  Mario Aranda-Bustos⁴  Carlos Peña-Farfal⁵ 

[1] Facultad de Ciencias, Universidad San Sebastián;Facultad de Farmacia, Universidad de Concepción, Barrio Universitario SN;Facultad de Ciencias, Universidad del Bio Bio;Departamento de Farmacia, Facultad de Química y de Farmacia, Pontificia Universidad Católica de Chile;Instituto de Ciencias Químicas Aplicadas, Facultad de Ingeniería, Universidad Autónoma de Chile

关键词: Caffeine;    Acetylsalicylic acid;    Paracetamol;    NIR;    pharmaceutical analysis;   

DOI  :  10.4067/s0717-97072021000405387

学科分类：化学（综合）

来源: Sociedad Chilena de Quimica

【 摘 要 】

Manufacturing pharmaceutical products is one of the most regulated industrial processes due to the importance of its effects on human health. These processes require many physical and chemical determinations through chromatographic techniques coupled with different detectors. However, the pharmaceutical industry is not considering the growth that spectroscopic techniques have had in these fields of application, especially to monitor the blending process.This study evaluates different sampling methods for pharmaceutical blending processes by near-infrared spectroscopy (NIRS) and Vis-NIR spectroscopy. The pharmaceutical mixture consisted of three active ingredients at different concentrations. Various qualitative and quantitative strategies were used to evaluate the endpoint of the blending process. The results revealed the feasibility of different spectral analyses to establish the homogeneity of the mixture, which may be especially useful for applications at the industrial level in routine analysis or as a first choice. HPLC confirmed the final blend.

【 授权许可】

Unknown