Avaliação de medicamentos industrializados contendo aciclovir através de espectroscopia por reflexão no infravermelho e análise multivariada.

Abstract

In this work, the Infrared reflectance spectroscopy associated with multivariate analysis ware used to analyses of pharmaceutical formulation containing acyclovir, a medicine chooses to treat herpes. There were acquired 25 ointment samples containing 5 % of acyclovir, in which it has acquired 22 samples of national market and 3 samples of Argentinean market. The ATR-FTIR spectra set was acquired in the 4,000 a 650 cm-1 range, with 4 cm-1 resolution and 32 scans, using an attenuated total reflectance accessory with a ZnSe crystal from PIKE Technologies attached to a NICOLET Magna 550 spectrophotometer. The ATR-NIR spectra set was acquired in the 10,001 to 2,001 cm-1 range, with a resolution of 4 cm-1 and 32 scans, using the total attenuated reflectance accessory with ZnSe crystal of Pike Technologies attached to a PERKIN ELMER Spectrum 400 MIR/NIR infrared spectrophotometer, and obtained only one spectrum of each sample. Finally, the NIRA spectra set was acquired in duplicate in the 8,890 to 4,200 cm1 range, using the PERKIN ELMER Spectrum 400 MIR/NIR infrared spectrophotometer attached to a accessory to transflectance (NIRA), using a detector of InGaAS stabilized with high performance. The spectra obtained have been treated with computer tools of multivariate analyses, using the principal components analysis (PCA) and hierarchical cluster analysis (HCA) algorithms, treated with the PIROUETTE 3.11 of INFOMETRIX, aiming to verify the similarity between the different pharmaceutical industries, lots and type (medicines of reference, generic and similar). Independently of the classification of the medicine as generic, similar or reference, all samples from the same laboratory always clustered, indicating that generic and similar medicines from them present similar compositions, showing that it might be the same medicine with a different label. The application of this infrared techniques (ATR/FTIR, ATR/NIR and NIRA) with the multivariate analyses (PCA and HCA) have been efficient to develop simpler, faster and non-destructive methodologies for the analysis of ointments containing acyclovir commercialized in Brazil and Argentina, highlighting the potentiality of these techniques in the control and inspection of industrialized medicines in these countries.