近红外光谱法测定头孢氨苄颗粒含量

Rapid Determination of Cefalexin Granules by NIR

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 develop a NIR method for rapid determination of Cefalexin granules. METHODS The NIR spectra of 187 batches of Cefalexin granules from different pharmaceutical manufacturers were collected, 94 spectra of them were used as the calibration set and the rest 93 spectra as the validation set. The quantitative model was set up and applied to predict the validation set and detect the samples. RESULTS For the quantitative determination, the concentration range of cephalexin was 0.042 0-0.138 0 mg·mg-1. The determination coefficients （R2） of the cross validation was 98.84, the true mean predictive error of root meansquare error of cross validation （RMSECV） was 0.003. The mean prediction error of root mean square error of prediction （RESEP） was 0.003, the correlation coefficient of the true value and prediction value was 0.995 0. CONCLUSION The method is simple, rapid and accurate, and can be applied to drug rapid determination.