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

阿奇霉素颗粒剂近红外通用性定量分析模型的建立(英文)

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%）.

用近红外漫反射光谱法建立了阿奇霉素颗粒剂的通用性定量分析模型。以21个厂家的103批阿奇霉素颗粒剂建立模型,其浓度范围为3.0%至24.5%。对模型进行外部验证,均方根差(RMSEP)为0.613。此外,还参照ICH的指导原则对模型进行方法学验证,验证项目有:专属性、线性、准确度和精密度。可见,通过选择合适的训练集样本,并精心的挑选建模谱段,建立阿奇霉素颗粒剂的近红外通用性定量分析模型是可行的,该模型可用于快速分析国内各厂家产品的含量。