近红外漫反射光谱法测定红霉素肠溶片中红霉素A的含量

Determination of erythromycin A in erythromycin enteric-coated tablets by near infrared diffuse reflectance spectrophotometry

目的:应用近红外漫反射技术和化学计量学的方法对红霉素肠溶片中的红霉素 A 进行定量分析。方法:通过偏最小二乘法建立数学模型,对预测集进行预测,并对实际样品的含量进行测定。结果:40个校正集样品经内部交叉验证建立校正模型,内部交叉验证确定系数 R^2=99.86,内部交叉验证均方根误差(RMSECV)为0.50。对10个预测集样品进行外部验证,预测均方根误差(RMSEP)为0.493,预测值与真实值的相关系数达0.9995。预测值的平均回收率为100.11%(RSD=0.96%,n=10),方法精密度 RSD 为0.78%(n=8)。方法稳定性 RSD 为0.95%(n=7)。结论:本方法快速简便,结果准确,适用于药品快速检查和质量控制。

Objective：Near infrared diffuse reflectance spectrophotometry（NIRDRS） and chemometrics were applied to the quantitative analysis of erythromycin A in erythromycin enteric - coated tablets. Method. PLS （ partial least squares） regression models were set up using a calibration set（40 samples）. The validation set was set up by 10 sampies. Applying this model to predict the validation set and detect the samples. Results：The determination coefficients R^2 was 99.86 as indicated from the cross -validation,the true mean predictive error RMSECV（root mean square error of cross validation） was 0. 50. The mean prediction error RMSEP （root mean square error of prediction） obtained from the validation was 0. 493 ,The correlation coefficient of the true value and prediction value from validation was 0. 9995. The average recovery of the prediction set was 100. 11% （RSD =0. 96% ,n = 10）. Conclusion：NIRDRS method is simple ,rapid and accurate. The method can be applied in rapid qualitative and quantitative analysis of drugs.