Browsing by Author "Cardona Moreno, Gilma Liliana"
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Item Implementación y validación de la técnica analítica para la cualificación–cuantificación de Dienogest/Etinilestradiol tableta recubierta, por espectroscopia de infrarrojo cercano(Universidad Santiago de Cali, 2018) Cardona Moreno, Gilma Liliana; Castillo, Jorge Enrique (Director)In this study, the implementation and validation of the analytical technique for the identification and quantification by NIR near infrared spectroscopy of Dienogest / Etinilestradiol in Coated Tablets was developed. This methodology was developed in order to provide a quick, simple and environmentally friendly analysis technique. To carry out this study, the spectra of 24 samples were collected, corresponding to 7 placebos loaded in a concentration range of 85 and 115%, 7 placebos loaded according to the DoE, 3 batches of finished product and 7 placebos loaded for validation. The NIR records were made in the diffuse reflectance mode and compared with the HPLC reference method. The PLS multivariate calibration method (partial regression by least squares) was used for the chemometric analysis of the data. The spectral correlation between the methods was established with correlation coefficients of (R2), in the range of 0.996 and 1.00. The validation process was developed based on the criteria of the EMA guide and demonstrated the compliance of the parameters of linearity, accuracy, specificity and precision, which guarantee and allow its application as a method of analysis for the control of the production process.