摘要
采用近红外漫反射光谱法和偏最小二乘回归算法建立了2种测样方式对不同厂家注射用头孢哌酮钠中头孢哌酮的含量进行快速测定的定量分析模型。对9个厂家的19批注射用头孢哌酮钠样品及其降解物中头孢哌酮的含量进行了预测,积分球模型的交叉验证均方根误差(RMSECV)和预测均方根误差(RMSEP)分别为0.636和2.01,光纤模型的交叉验证均方根误差(RMSECV)和预测均方根误差(RMSEP)分别为0.857和3.71。根据ICH指导原则,从专属性、线性、重现性、稳定性、准确性等几个方面对两模型的方法进行了验证,进而说明光纤测样方式建立的模型专属性和适用性均良好,完全可以对不同生产厂家的同一品种的药品进行快速的初步定量分析,适用于药品检验车的快速无损检测。
Universal quantitative models using NIR reflectance spectroscopy in two different kinds of sampling mode were developed for the analysis of cefoperazone sodium for injection from different manufacturers in China. The quantitative models were established using partial least squares（PLS）. Nineteen batches of cefoperazone sodium for injection samples from 9 different manufacturers were predicted by the quantitative models. The root mean square errors of cross validation （RMSECV） and the root mean square errors of prediction （RMSEP） of the model in integrating sphere sampling mode were 0. 99 and 0. 98, respectively. The values of RMSECV and RMSEP of the model in fibre sampling mode were 1.12 and 1.17, respectively. Based on the ICH guidelines and characteristics of NIR spectra, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, and precision The authors＇ study has shown that it is feasible to build a universal quantitative model in fibre sampling mode for quick analysis of pharmaceutical products from different manufacturers. As a result of its good specificity and applicability, the model could be used for quick, non-destructive prescreening of counterfeit and substandard drugs in the mobile vehicle.
出处
《光谱学与光谱分析》
SCIE
EI
CAS
CSCD
北大核心
2006年第12期2214-2218,共5页
Spectroscopy and Spectral Analysis
基金
国家财政部重点项目资助
关键词
近红外漫反射光谱
定量分析
方法验证
快速检测
头孢哌酮
NIR reflectance spectroscopy
Quantitation
Validative analysis
Quick inspection
Cefoperazone
