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目的建立测定头孢氨苄颗粒含量的近红外光谱(NIR)快速分析方法。方法以全国不同企业生产的187批头孢氨苄颗粒样品采集近红外光谱,分别建立校正集和检验集,校正集经内部交叉验证,建立校正模型,对检验集的样品进行分析。结果头孢氨苄颗粒的浓度为0.042 0~0.138 0 mg·mg-1,内部交叉验证决定系数(R2)为98.84,内部交叉验证均方差(RMSECV)为0.003,外部验证预测均方差(RMSEP)为0.003,预测值与真值的相关系数为0.995 0。结论所建方法快速、简便、结果准确,可用于头孢氨苄颗粒的快速定量检验。
Objective To establish a rapid method for the determination of cefalexin particles by near infrared spectroscopy (NIR). Methods A total of 187 samples of cephalexin produced by different enterprises in China were collected by near infrared spectroscopy. Calibration sets and test sets were established respectively. The calibration set was calibrated by internal cross-validation and the calibration model was established. Samples of the test set were analyzed. Results The concentration of cefalexin granules was 0.042 0-0.1380 mg · mg -1, the internal cross validation coefficient was 98.84, the RMSECV was 0.003, and the RMSEP was 0.003 , The correlation coefficient between predicted value and true value is 0.995 0. Conclusion The method is rapid, simple and accurate. It can be used for the rapid quantitative determination of cephalexin particles.