Construction of a universal quantitative model for the determination of azithromycin in granules using near-infrared diffuse reflectance spectroscopy

doi:10.5246/jcps.2012.05.060

Abstract

Abstract:

A universal quantitative model was developed to determine the azithromycin content in granules using near infrared (NIR) diffuse reflectance spectroscopy. The diffuse reflection spectra were recorded with the integrating sphere at 8 cm^-1 resolution in 4000-12 000 cm^-1 spectral range. During each measurement, 32 co-added scans were performed. This quantitative model was constructed with 103 batches of azithromycin granules from 21 different manufacturers. The azithromycin content ranges from 3.0% to 24.5%. The root mean square error of prediction (RMSEP) of model was 0.613. In addition, the quantitative model was evaluated in terms of specificity, linearity, accuracy, and precision according to ICH guidelines. In conclusion, it is feasible to construct a universal quantitative model for azithromycin granules by choosing suitable training set samples and selecting an appropriate wavelength range. The quantitative model could be applied in the quick assay of azithromycin granules produced by domestic manufacturers (content: 3.0%-24.5%).

Key words: NIR, Azithromycin, Granule

CLC Number:

R917

Supporting:

Wenbo Zou, Yanchun Feng, Danqing Song, Changqin Hu^* . Construction of a universal quantitative model for the determination of azithromycin in granules using near-infrared diffuse reflectance spectroscopy[J]. , DOI: 10.5246/jcps.2012.05.060.

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