近红外漫反射光谱法快速测定氨苄西林胶囊的含量

目的: 应用近红外漫反射(NIRDRS)技术和化学计量学的方法对氨苄西林胶囊进行定量分析,无损、快速测定。 方法: 以全国范围内不同企业生产的氨苄西林胶囊为分析对象,用光纤测定近红外漫反射光谱,通过偏最小二乘法(PLS)建立数学模型,对预测集进行预测。 结果: 对氨苄西林胶囊进行定量分析,建立定量分析模型,由39个样品经内部交叉验证(calibration spectra),浓度范围为68.83%~84.94%,16个样品用于外部验证(Test Spectra),浓度范围为69.07%~84.42%,相关系数为0.9901,训练集(TEST SET VALIDATION)外部检验均方差(RMSEP)为1.7,确定系数R²=85.38,RANK 为6; 检验集(CROSS VALIDATION)交叉验证均方差(RMSECV)为1.67,确定系数R²=81.58,RANK 为5。 结论: 定量模型可按照中国药典要求对氨苄西林胶囊进行快速预测分析,方法快速、简便,可用于药品的快速检验。

Objective: A near-infrared quantitative method was developed for rapid and nondestructive determination of ampicillin capsules. Methods: The diffuse reflectance near-infrared spectra of ampicillin capsules from different pharmaceutical factories in China were measured intactly by a fiber optic probe.The calibration model was developed using partial least squares(PLS)algorithm. Result: For the quantitative model of ampicillin capsules content,39 batches of ampicillin capsules were used as calibration set,the concentration range was 68.83%-84.94%,and 16 batches as validation set.The concentration range was 69.07%-84.42%,and the correlation coefficient of cross validation was 0.9901,the root mean square error df cross validation (RMSECV) was 1.7 and R²=85.38,and(RMSEP) was 1.67 and R²=81.58. Conclusin: Using the two quantitative models,we can quickly evaluate Ampicillin capsules according to ChP.The method is simple and rapid,the NIRDRS result can be usd in the mobile lab.