Nir-chemical imaging study of acetylsalicylic acid in commercial tablets.

Near Infrared Chemical Imaging (NIR-CI) is demonstrating an increasing interest in pharmaceutical research since it meets the challenging analytical needs of pharmaceutical quality and may serve as a versatile adjunct to conventional NIR spectroscopy in many fields. The direct analysis of samples by using hyperspectral imaging techniques, which provide a NIR spectrum in each pixel of the image, generates a big amount of information from one sample. Focusing the interest in pharmaceutical research, several chemometric algorithms are demonstrating their usefulness extracting the relevant information (i.e. quantitative determination of the component in one sample) in tablets with only one sample and without damaging it. In this work, a quantitative method to analyze different commercial Acetylsalicylic acid tablets is proposed by using Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) method to the hyperspectral image and without any previous calibration model. For this purpose, a large concentration range of active pharmaceutical ingredient (ASA, Acetylsalicylic acid in this work), between 82% and 12%, was covered depending on the manufacturer. MCR-ALS allowed obtaining a concentration maps for acetylsalicylic acid and therefore, consequent analysis of the ASA distribution in the tablet was developed by using the histograms of the distribution of concentration. Results certified the good distribution of ASA despite the different origins of the tablets. Moreover, the obtained values of concentration showed a very good concordance with the nominal value of ASA. As a matter of fact, the quality of the results demonstrated the useful of encompassing NIR-CI techniques with MCR-ALS and, consequently, the well development on the production of Acetylsalicylic acid tablets.

[1]  Wim Jiskoot,et al.  Near-Infrared Imaging for Studying Homogeneity of Protein-Sugar Mixtures , 2006, Pharmaceutical Research.

[2]  E. Lewis,et al.  A near Infrared View of Pharmaceutical Formulation Analysis , 2001 .

[3]  S. Kazarian,et al.  Effect of moisture and pressure on tablet compaction studied with FTIR spectroscopic imaging. , 2007, Journal of pharmaceutical sciences.

[4]  Harumi Sato,et al.  Evaluation of Homogeneity of Binary Blends of Poly(3-hydroxybutyrate) and Poly(l-lactic acid) Studied by Near Infrared Chemical Imaging (NIRCI) , 2007, Analytical sciences : the international journal of the Japan Society for Analytical Chemistry.

[5]  Romà Tauler,et al.  A graphical user-friendly interface for MCR-ALS: a new tool for multivariate curve resolution in MATLAB , 2005 .

[6]  Robert A. Lodder,et al.  Applications of integrated sensing and processing in spectroscopic imaging and sensing , 2005 .

[7]  Boiana O. Budevska,et al.  Application of Multivariate Curve Resolution for Analysis of FT-IR Microspectroscopic Images of in Situ Plant Tissue , 2003, Applied spectroscopy.

[8]  C. Gendrin,et al.  Content uniformity of pharmaceutical solid dosage forms by near infrared hyperspectral imaging: A feasibility study. , 2007, Talanta.

[9]  M Blanco,et al.  Preparing calibration sets for use in pharmaceutical analysis by NIR spectroscopy. , 2008, Journal of pharmaceutical sciences.

[10]  José Manuel Amigo,et al.  Study of pharmaceutical samples by NIR chemical-image and multivariate analysis , 2008 .

[11]  S. Sonja Sekulic,et al.  Multivariate data analysis for Raman imaging of a model pharmaceutical tablet , 2005 .

[12]  F. Clarke,et al.  Chemical image fusion. The synergy of FT-NIR and Raman mapping microscopy to enable a more complete visualization of pharmaceutical formulations. , 2001, Analytical chemistry.

[13]  Romà Tauler,et al.  Multivariate Curve Resolution (MCR) from 2000: Progress in Concepts and Applications , 2006 .

[14]  P. Geladi,et al.  Multivariate image analysis , 1996 .

[15]  L. Danielsson,et al.  Quantitative in-line monitoring of powder blending by near infrared reflection spectroscopy , 2002 .

[16]  P. K. Aldridge,et al.  On-line monitoring of powder blend homogeneity by near-infrared spectroscopy. , 1996, Analytical chemistry.

[17]  R. Bro,et al.  Near-infrared chemical imaging (NIR-CI) on pharmaceutical solid dosage forms-comparing common calibration approaches. , 2008, Journal of pharmaceutical and biomedical analysis.

[18]  D. Massart,et al.  Near-infrared spectroscopy applications in pharmaceutical analysis. , 2007, Talanta.

[19]  Romà Tauler,et al.  Spectroscopic imaging and chemometrics: a powerful combination for global and local sample analysis , 2004 .

[20]  Yukihiro Ozaki,et al.  Self-modeling curve resolution (SMCR) analysis of near-infrared (NIR) imaging data of pharmaceutical tablets. , 2008, Analytica chimica acta.

[21]  F. Clarke Extracting process-related information from pharmaceutical dosage forms using near infrared microscopy , 2004 .