近红外漫反射光谱法对阿莫西林胶囊的定性及定量分析  

Qualitative and Quantitative Assay of Amoxicillin Capsules by NIR Diffuse Reflectance Spectroscopy

作　　者：沈漪[1] 潘颖[1] 刘全 项竞佐[1] 

机构地区：[1]上海市药品检验所,上海200233 [2]美国Thermo Nicolet公司

出　　处：《药物分析杂志》2005年第4期385-389,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用近红外漫反射光谱分析技术对阿莫西林胶囊进行定性和定量分析。方法:按阿莫西林胶囊配方组成配制含主药阿莫西林浓度范围从5.91%-84.13%的32个实验室样品,并收集来源于9个厂家的41批工业样品,采集其近红外光谱。分别采用判别分析和偏最小二乘回归法建立定性和定量分析模型,将其用于对未知样品含量及生产厂家进行预测分析,并对定量分析方法的重现性和加样回收率进行考察。结果:定性分析模型对18个预测样品的判错数为0。定量分析模型对24个未知样品的预测均方差 RMSEP 为1.22%,预测值与真值的相关系数 r 为0.9983,加样平均回收率为99.75%,系统精密度 RSD 为0.3%,方法精密度 RSD 为0.6%。结论:用近红外光谱分析技术对阿莫西林胶囊进行定性和定量分析结果准确可靠,方法简便快速,不需预处理,可推广用于此类样品工业现场的原位和在线检测。Objective:To determine qualitatively and quantitatively amoxicillin capsules by near-infrared(NIR) diffuse reflectance spectroscopy.Method:We prepared 32 samples with concentration range of amoxicillin from 5.91% to 84.13%,at the same time collected 41 batches of samples from 9 factories,then use discriminant analysis to build classification model and use partial least square (PLS)to build the calibration model to predict the concen- tration of unknown sample,and examine the reproducibility and recovery of the method.Results:The misclassified sample is 0 using the qualitative model built by discriminant analysis.The root mean square error of prediction (RMSEP) obtained from the validation including 24 unknown samples is 1.22%,the correlation coefficient between the true value and prediction value is 0.9983.The average recovery is 99.75%,RSD of the system precision is 0.3%,RSD of the method precision is 0.6%.Conclusion:The results show that the predict model using NIR is re- liable,the method is fast and exact,and can be applied to on-line detection.

关 键 词：阿莫西林胶囊 近红外漫反射光谱法 定性 近红外光谱分析技术 分析模型 定量分析方法 偏最小二乘 加样回收率 平均回收率 浓度范围 配方组成 判别分析 预测分析 生产厂家 样品含量 相关系数 分析结果 在线检测 RSD 精密度 

分 类 号：R978.11[医药卫生—药品] R917[医药卫生—药学]