Construction and validation of conformity test model for zidovudine film-coated tablets by near infrared reflectance spectroscopy / 国际药学研究杂志

ABSTRACT

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.