A near-infrared diffuse reflectance spectroscopy method for rapid determination of ceftazidime,water content and arginine in ceftazidime for injection

Objective:To develop a near-infrared diffuse reflectance spectroscopy(NIRDRS) quantitative method for rapid and nondestructive determination of ceftazidime,water content and arginine in ceftazidime for injection.Methods:The diffuse reflectance near-infrared spectra of ceftazidime for injection from different pharmaceutical factories in China were measured intactly by a fiber optic probe.In order to expand the concentration range,we prepared samples by adding Na2CO3 or arginine.The calibration model was developed using partial least squares(PLS) algorithm.Results:For the quantitative model of arginine content,20 batches of ceftazidime for injection samples were used as correlation set,and 13 batches as validation set.The concentration range was 4.69%-32.74%,and the correlation coefficient of cross validation was 0.9948,the root mean square error of cross validation(RMSECV) was 0.0109 and the root mean square error of prediction was 0.0106; For the quantitative model of water content,21 batches of ceftazidime for injection samples were used as correlation set,and 21 batches as validation set.The concentration range was 3.13%-14.70%,and the correlation coefficient of cross validation was 0.9993,the root mean square error of cross validation(RMSECV) was 0.00314 and the root mean square error of prediction was 0.00188;For the quantitative model of ceftazidime content,25 batches of ceftazidime for injection samples were used as correlation set,and 22 batches as validation set.The concentration range was 35.96%-84.59%,and the correlation coefficient of cross validation was 0.9836,the root mean square error of cross validation(RMSECV) was 0.0249 and the root mean square error of prediction was 0.0234.Conclusion:The established NIR method is reliable for predicting the ceftazidime,it is fast and exact and can be used in the mobile lab.