[Construction of universal quantitative models for determination of cefoperazone sodium for injection from different manufacturers using near infrared reflectance spectroscopy].
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.
Pang
Huan-huan
HH
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Feng
Yan-chun
YC
Hu
Chang-qin
CQ
Xiang
Bing-ren
BR
D002438:Cefoperazone / Q000032:analysis* / Q000737:chemistry; D016018:Least-Squares Analysis; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared
D002438:Cefoperazone