Abstract
In this study, we developed a quantitative model using near-infrared (NIR) diffuse reflection spectroscopy to analyze active pharmaceutical ingredient (API) contents in ibuprofen sustained-release capsules from seven different major manufacturers in mainland China. Our quantitative model was based on 117 batches of ibuprofen samples with the API contents ranging from 73.6% to 85.4%. The root mean square errors of cross validation (RMSECV) and the root mean square errors of prediction (RMSEP) of the model for ibuprofen sustained-release capsule were 1.14% and 0.85%, respectively. Then, we evaluated this model in terms of outlier diagnostics, accuracy, precision, robustness and model transferability. Our results showed that it was feasible to build a universal quantitative model for ibuprofen sustained-release capsules. Therefore, NIR could be used as an effective method for quick and non-destructive inspection of ibuprofen in the distribution channels or open market.
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