近红外漫反射光谱法测定头孢克肟颗粒含量

Development of Near-infrared Method for Rapid Determination of Content of Cefixime Granules

目的 建立测定头孢克肟颗粒含量的近红外光谱（NIR）快速分析法.方法 以全国不同企业生产的头孢克肟颗粒为分析对象,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4597.5～6 101.7 cm-1,采用偏最小二乘回归算法（PLS）.结果 定量分析模型由77个样品经内部交叉验证,30个样品用于外部验证,浓度范围为2.4％～5.2％,相关系数为0.970 7,交叉验证均方差（RMSECV）为0.142％,相对标准偏差＜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 NIR method was developed for rapid determination of content of cefixime granules. Methods The diffuse reflectance near-infrared spectra of cefixime granules from different pharmaceutical factories in China weredetermined by a fiber optic probe. For quantitative analysis, the first derivative combining vector normalization method was usedfor pre-treatment of the spectra, the wavelength rang of 4 597. 5-6 101. 7 cm-1 was selected to set up the calibration curve by thePartial Least-squares Regression（PLSR）method. Results For the quantitative model, 77 batches were used as calibration set,and 30 batches as validation set, the concentration range was 2. 4% -5. 2%, and the correlation coefficient of cross validationwas 0. 970 7, the RMSECV was 0. 142%, and the RSD was less than 5%. Conclusion The method is simple, rapid, andcan be applied for rapid determination of the content of Cefixime granules.