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      • Quality assessment of pharmaceutical tablet samples using Fourier transform near infrared spectroscopy and multivariate analysis

        Kandpal, Lalit Mohan,Tewari, Jagdish,Gopinathan, Nishanth,Stolee, Jessica,Strong, Rick,Boulas, Pierre,Cho, Byoung-Kwan Elsevier 2017 Infrared physics & technology Vol.85 No.-

        <P><B>Abstract</B></P> <P>Determination of the content uniformity, assessed by the amount of an active pharmaceutical ingredient (API), and hardness of pharmaceutical materials is important for achieving a high-quality formulation and to ensure the intended therapeutic effects of the end-product. In this work, Fourier transform near infrared (FT-NIR) spectroscopy was used to determine the content uniformity and hardness of a pharmaceutical mini-tablet and standard tablet samples. Tablet samples were scanned using an FT-NIR instrument and tablet spectra were collected at wavelengths of 1000–2500nm. Furthermore, multivariate analysis was applied to extract the relationship between the FT-NIR spectra and the measured parameters. The results of FT-NIR spectroscopy for API and hardness prediction were as precise as the reference high-performance liquid chromatography and mechanical hardness tests. For the prediction of mini-tablet API content, the highest coefficient of determination for the prediction ( <SUP> R 2 </SUP> p ) was found to be 0.99 with a standard error of prediction (SEP) of 0.72mg. Moreover, the standard tablet hardness measurement had a <SUP> R 2 </SUP> p value of 0.91 with an SEP of 0.25kg. These results suggest that FT-NIR spectroscopy is an alternative and accurate nondestructive measurement tool for the detection of the chemical and physical properties of pharmaceutical samples.</P> <P><B>Highlights</B></P> <P> <UL> <LI> FT-NIR technique was used for investigation of content uniformity and hardness of pharmaceutical tablet samples. </LI> <LI> Multivariate analysis predicted API and hardness of tablets with higher accuracy. </LI> <LI> FT-NIR demonstrated a great potential tool for detection of chemical and physical properties of the pharmaceutical samples. </LI> </UL> </P>

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