Author(s): Pang HH, Feng YC, Hu CQ, Xiang BR
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Abstract Universal quantitative models using NIR reflectance spectroscopy in two different kinds of sampling mode were developed for the analysis of cefoperazone sodium for injection from different manufacturers in China. The quantitative models were established using partial least squares(PLS). Nineteen batches of cefoperazone sodium for injection samples from 9 different manufacturers were predicted by the quantitative models. The root mean square errors of cross validation (RMSECV) and the root mean square errors of prediction (RMSEP) of the model in integrating sphere sampling mode were 0. 99 and 0. 98, respectively. The values of RMSECV and RMSEP of the model in fibre sampling mode were 1. 12 and 1. 17, respectively. Based on the ICH guidelines and characteristics of NIR spectra, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, and precision. The authors' study has shown that it is feasible to build a universal quantitative model in fibre sampling mode for quick analysis of pharmaceutical products from different manufacturers. As a result of its good specificity and applicability, the model could be used for quick, non-destructive prescreening of counterfeit and substandard drugs in the mobile vehicle.
This article was published in Guang Pu Xue Yu Guang Pu Fen Xi
and referenced in Journal of Analytical & Bioanalytical Techniques