Résumé
Objective To establish a conformity test model for inspecting aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets by near infrared reflectance(NIR)spectroscopy respectively. Methods The method of first derivative and vector normalization was employed respectively to pretreat the corresponding NIR spectra of aluminum-plastic pack?age and removed aluminum-plastic package zidovudine film-coated tablets with the spectral ranges of 12000~4000 cm-1. The optimum modeling band were 9000-7500cm-1,6900-5600 cm-1and 5000-4250 cm-1,respectively,and the smoothing point was set as 17 and CI limit was 7. The conformity test model was constructed on the basis of the above parameters and validated respectively. Results The authentic aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets were distinguished from inauthentic ones using the conformity test model validated by spectra collected by different inspectors and different near infrared instruments,realizing the model transfer accurately and effectively and improving the universality of NIR calibration model. Conclu?sion The conformity test model is accurate,simple,feasible,and suitable for the drug examination of zidovudine film-coated tablets.
Résumé
Objective To establish a conformity test model for inspecting aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets by near infrared reflectance(NIR) spectroscopy respectively. Methods The method of first derivative and vector normalization was employed respectively to pretreat the corresponding NIR spectra of aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets with the spectral ranges of 12000~4000 cm-1. The optimum modeling band were 9000-7500cm-1, 6900-5600 cm-1and 5000-4250 cm-1, respectively, and the smoothing point was set as 17 and CI limit was 7. The conformity test model was constructed on the basis of the above parameters and validated respectively. Results The authentic aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets were distinguished from inauthentic ones using the conformity test model validated by spectra collected by different inspectors and different near infrared instruments, realizing the model transfer accurately and effectively and improving the universality of NIR calibration model. Conclusion The conformity test model is accurate, simple, feasible, and suitable for the drug examination of zidovudine film-coated tablets.
Résumé
Objective:To develop a method of near infrared reflectance spectroscopy ( NIRS) for the rapid determination of peflox-acin mesylate for injection .Methods:The quantitative models were established by the collection of NIR spectra of pefloxacin mesylate for injection.The spectra were pretreated with the methods of vector normalization , and the spectral ranges of 9 176.2-8 169.5 cm-1 , 6 051.9-5 716.3 cm-1 and 4 509-3 999.9 cm-1 were chosen.The partial least square (PLS) was used as the regression method .Re-sults:The prediction model was established by the internal cross validation ,and the concentration range was 7.55%-77.69%.The root mean square error of cross validation (RMSECV) was 1.61%, and the correlation coefficient was 0.992 4.Conclusion: The method of near infrared reflectance spectroscopy can be used for the rapid quantitative analysis of pefloxacin mesylate for injection .