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| Author(s): |
Renato Lajarim Carneiro
Total Authors: 1
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| Document type: | Doctoral Thesis |
| Press: | Campinas, SP. |
| Institution: | Universidade Estadual de Campinas (UNICAMP). Instituto de Química |
| Defense date: | 2010-01-22 |
| Examining board members: |
Ronei Jesus Poppi;
Edenir Rodrigues Pereira Filho;
Gilmare Antonia da Silva;
Maria Izabel Maretti Silveira Bueno;
Fabio Augusto
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| Advisor: | Ronei Jesus Poppi |
| Abstract | |
Chemometric methods were studied for exploratory and quantitative analysis of pharmaceutical preparations using near and mid infrared (NIR and MIR) imaging spectroscopy. Three applications were accomplished as follows: 1st Exploratory analysis to diagnose phase separation in a ointment formulation. It was used Principal Component Analysis (PCA) and Multivariate Curve Resolution - Alternating Least Squares (MCR-ALS) methods. Phase separation was observed between ointment base (vehicle) and solvent of the active ingredient (API); 2nd Exploratory analysis to diagnose crystallization process in a cream (emulsion). It was used PCA and MCR-ALS methods. Crystallization was observed after stability period due precipitation of a API salt; 3rd Determination of superficial distribution of the API and excipients in tablets in order to evaluate sample homogeneity. PCA models were used for exploratory analysis and Interval Partial Least Squares (iPLS) model was applied for API and excipient quantification. Concentration maps of tablets showed good API and excipient homogeneity, except for a few large crystals. These applications showed that imaging spectroscopy is a powerful tool for homogeneity studies of pharmaceutical preparations. Results of three applications could be visually interpreted through absorption, score and concentration maps. (AU) | |