The general strategy and method of constructing universal calibration model for levofioxacin injections by near-infrared spectroscopy have been investigated and discussed. Firstly, a constant-temperature homogeneous l...The general strategy and method of constructing universal calibration model for levofioxacin injections by near-infrared spectroscopy have been investigated and discussed. Firstly, a constant-temperature homogeneous liquid calibration model for levofloxacin hydrochloride injections with the same composition but different active principal ingredient （API） content was established as the basic unit for universal model. Then, samples of levofloxacin hydrochloride injections containing propylene glycol or levofloxacin lactate injections were added to develop a primary constant-temperature liquid universal model. Temperature- amended final universal model was established to apply to samples under different temperatures. The final model was built from 61 calibration samples and 77 validation samples. The value of the root mean square error of cross validation （RMSECV） and coefficient of determination （r2） of leave-one-out cross-validation （LOOCV） were 0.792 and 0.9993, respectively, the root mean square error of prediction （RMSEP） of test set validation （TSV） was 0.87, and the average relative deviation was 1.44%. According to the ICH guidelines, the universal calibration model was evaluated. Based on the experimental statistical results, the recommended number of calibration samples for a constant-temperature homogeneous liquid quantitative model was no less than 15.展开更多
基金National Science and Technology Major Project of the Ministry of Science and Technology of China(Grant No. 2010ZX09401-403)
文摘The general strategy and method of constructing universal calibration model for levofioxacin injections by near-infrared spectroscopy have been investigated and discussed. Firstly, a constant-temperature homogeneous liquid calibration model for levofloxacin hydrochloride injections with the same composition but different active principal ingredient （API） content was established as the basic unit for universal model. Then, samples of levofloxacin hydrochloride injections containing propylene glycol or levofloxacin lactate injections were added to develop a primary constant-temperature liquid universal model. Temperature- amended final universal model was established to apply to samples under different temperatures. The final model was built from 61 calibration samples and 77 validation samples. The value of the root mean square error of cross validation （RMSECV） and coefficient of determination （r2） of leave-one-out cross-validation （LOOCV） were 0.792 and 0.9993, respectively, the root mean square error of prediction （RMSEP） of test set validation （TSV） was 0.87, and the average relative deviation was 1.44%. According to the ICH guidelines, the universal calibration model was evaluated. Based on the experimental statistical results, the recommended number of calibration samples for a constant-temperature homogeneous liquid quantitative model was no less than 15.
