Raman spectral imaging technique for API detection in pharmaceutical microtablets

• DOI: 10.1016/j.snb.2017.12.178
• Publication Date: 2017-12-28T17:58:50Z
• Authors: Lalit Mohan Kandpal; Byoung-Kwan Cho; Jagdish Tewari; Nishanth Gopinathan
• Keywords: Process Analytical Technology; Chemometrics; Chemical Imaging

Abstract In pharmaceutical manufacturing, quality monitoring of end products is essential to gain regulatory approval. In particular, monitoring the quantity of an active pharmaceutical ingredient (API) in the administered dosage is key to ensuring the content uniformity of the product. Thus, we herein aim to demonstrate the ability of the newly developed line-scan Raman hyperspectral imaging (RHSI) technique for the quantitative analysis of APIs in microtablet samples. Microtablets containing the API of interest and appropriate excipients of varying concentrations (i.e., 60–130% (w/w) API) were prepared by direct compression. The microtablet RHSI spectra were obtained over a wavelength range of 400–1800 cm−1. High-performance liquid chromatography was also employed as a reference method for the API assay. Multivariate analysis methods, including partial least squares and least-squares support vector machines, were employed to predict the API concentrations using the spectral and reference values of the microtablets. The developed models exhibited excellent prediction abilities for the API concentration, with a coefficient of correlation (R2) >0.95, which was associated with an error of