头孢克肟片含量的近红外漫反射光谱法测定

Development of an NIR Method for Rapid Determination of Cefixime Tablets

目的:建立测定头孢克肟片含量的近红外光谱(NIR)快速分析分析方法:以全国不同企业生产的头孢克肟片为分析对象,用光纤探头测定近红外漫反射光谱;定量模型的预处理方法为一阶导数与矢量归一化,波数范围为11 995.2～7 498cm^(-1)和5 453.8～4 597.5 cm^(-1),采用偏最小二乘回归算法(PLS)。结果:定量分析模型由76个样品经内部交叉验证建立,40个样品用于外部验证,浓度范围为13.5%～54.2%,相关系数为0.989 4,交叉验证均方差(RMSECV)为1.53%,相对偏差小于5%。结论:该方法快速、简便,具有一定的专属性,可用于药品的快速检验。

Objective：To establish an NIR method for the rapid determination of cefixime tablets.Method：The NIR of cefixime tablets from different pharmaceutical factories in various areas in China was determined by a fiber optic probe.For quantitative analysis, the first derivative combined with vector normalization method was used in the pre-treatment of the spectra with the wave number range of 11 995.2-7 498 cm^（-1） and 5453.8-4597.5 cm^（-1） to obtain the calibration curve by the partial least-squares regression （PLSR） method.Result：For the quantitative model,76 batches were used as the calibration set,and 40 batches as the validation set,the concentration range was 13.5%-54.2%,the correlation coefficient of cross validation was 0.989 4,RMSECV was 1.53% and RSD was less than 5%.Conclusion：The method is simple and rapid,and can be applied in the drug rapid determination.