近红外光谱法快速分析盐酸头孢他美酯片的含量和水分  

Determination of Content and Water in Cefetamet Pivoxil Hydrochloride Tablets by Near Infrared Diffuse Reflectance Spectrophotometry

作　　者：黄丽丽 朱健萍 朱斌 丁丽霞[2] 

机构地区：[1]广西食品药品检验所,南宁530021 [2]中国食品药品检定研究院

出　　处：《中国药师》2016年第8期1590-1592,共3页China Pharmacist

基　　金：十二五国家科技重大专项"重大新药创制"课题(编号:2011ZX09303-001)

摘　　要：目的:应用近红外漫反射技术和化学计量学的方法对盐酸头孢他美酯片的含量和水分进行分析。方法:通过建立数学模型,测定实际样品的含量,并以相关性分析和回归分析法对HPLC法和近红外光谱法(NIR法)测定结果进行比较分析。结果:25个样品经内部交叉验证建立模型,内部交叉验证确定系数R^2分别为93.81(含量)和98.65(水分),均方差RMSECV分别为0.112(含量)和0.030 5(水分),方法精密度RSD为0.15%(n=6)。NIR法与HPLC法测定数据相关性较好。结论:本方法快速简便,结果准确,适用于企业开展快速定量分析,实现产品在线分析。Objective： To develop a near infrared diffuse reflectance spectroscopy（ NIRS） method and a chemometrics method for the determination of content and water in cefetamet pivoxil hydrochloride tablets. Methods： A mathematics model was set up to determine cefetamet pivoxil hydrochloride using a calibration set（ 25 samples）. The results of NIRS and HPLC were analyzed by correlation and regression methods. Results： The determination coefficients R^2 were 93. 81（ content） and 98. 65（ water） as indicated by the crossvalidation,and the true mean predictive errors of root mean square error of cross validation（ RMSECV） were 0. 112（ content） and0. 030 5（ water）. The recovery of the prediction set was 99. 8% and the RSD for the precision was 0. 15%（ n = 6）. Both of NIRS and HPLC results were perfectly relative. Conclusion： The NIRS method is accurate and rapid,which can be used as a quick quantitative analysis to control cefetamet pivoxil hydrochloride online.

关 键 词：盐酸头孢他美酯片 近红外光谱法 含量 水分 

分 类 号：R927.2[医药卫生—药学]