Construction of universal calibration model for levofloxacin injections by fiber-optic transmittance-reflectance near-infrared spectroscopy

doi:10.5246/jcps.2012.01.008

Abstract

Abstract:

The general strategy and method of constructing universal calibration model for levofloxacin 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.

Key words: Near-infrared spectroscopy, Liquid universal calibration model, Levofloxacin injection, Sampling by fiber-optic transmittance-reflectance mode

CLC Number:

R917

Supporting:

Shao-Rui Hou, Yan-Chun Feng, Xue-Bo Zhang, Chang-Qin Hu^*. Construction of universal calibration model for levofloxacin injections by fiber-optic transmittance-reflectance near-infrared spectroscopy [J]. , DOI: 10.5246/jcps.2012.01.008.

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