近红外光谱法快速分析头孢氨苄片

目的: 建立测定头孢氨苄片含量的近红外光谱(NIR)快速分析方法。 方法: 以全国不同企业生产的头孢氨苄片建立校正集,采集其近红外漫反射光谱,经内部交叉验证,建立校正模型,进而对预测集的样品进行分析。 结果: 头孢氨苄糖衣片的浓度范围为0.2569~0.6039 mg·mg^-1,头孢氨苄薄膜衣片的浓度范围为0.3478~0.8755 mg·mg^-1,内部交叉验证决定系数(r)分别为94.31,97.92,内部交叉验证均方差(RMSECV)为1.98,1.55,外部验证预测均方差(RMSEP)为1.58,1.22,预测值与真值的相关系数为0.9799,0.9894。 结论: 该法具有快速、简便、结果准确的特点,可用于头孢氨苄片药品的快速检验。

Objective: To develop a NIR method for rapid determination of cefalexin tablets. Method: Collect cefalexin tablet samples from different pharmaceutical factories all over the in this country,and scan their NIR spectra.Then correlate these data and get the best-fitted model.Applying this model to predict the validation set and detect the samples. Results: For the quantitative determination,the concentration range was 0.2569-0.6039 mg·mg^-1 (cefalexin sugar tablets),0.3478-0.8755 mg·mg^-1 (cefalexin film tablets).The determination coefficients (r) was 94.31,97.92 as indicated from the cross-validation,the true mean predictive error RMSECV(root mean square error of cross validation)was 1.98,1.55.The mean prediction error RESEP(root mean square eror of prediction)obtained from the validation was 1.58,1.22,the correlation coeficient of the true value and prediction value was 0.9799,0.9894. Conclusions: The method is simple,rapid and accurate,and can be applied to drug rapid determination.