近红外光谱法测定盐酸环丙沙星片中环丙沙星

目的 利用近红外光谱（NIR）分析技术和化学计量学方法对盐酸环丙沙星片进行无损、快速定量分析。方法 以不同生产企业生产的盐酸环丙沙星片为分析对象，用光纤探头测定其近红外漫反射光谱；定量模型的预处理方法为二阶导数，波长范围为6 101.9～4 555.2 cm^-1，采用偏最小二乘法（PLS）建立分析模型。结果 定量分析模型由93批样品经内部交叉验证建立，177批样品进行外部验证，环丙沙星质量分数范围为54.20%～82.54%，相关系数为0.986 3，交叉验证均方差（RMSECV）为1.06，外部验证均方差（RMSEP）为0.92。结论 该方法快速、简便具有一定的专属性，可用于盐酸环丙沙星片中环丙沙星的快速定量分析。

Determination of ciprofloxacin in Ciprofloxacin Hydrochloride Tablets by near-infrared method

Objective To develope near-infrared (NIR) method and chemometrics method for the rapid and nondestructive determination of Ciprofloxacin Hydrochloride Tablets. Methods The diffuse reflectance NIR spectra of Ciprofloxacin Hydrochloride Tablets from different pharmaceutical factories were measured intactly by a fiber optic probe; The pretreatment method of quantitative models was the second derivative; The wavelength rang of 6 101.9-4 555.2 cm^-1 was selected, the calibration model was developed using partial least squares (PLS) algorithm. Results For the quantitative model, 93 batches of samples were used as calibration set, and 177 batches of samples as validation set. The content range of ciprofloxacin was 54.20%-82.54%, the correlation coefficient of cross validation was 0.986 3, the root mean square error of cross validation (RMSECV) was 1.06, and the root mean square error of prediction (RMSEP) was 0.92. Conclusion The method is simple, rapid, and can be applied to rapid quantitative analyses of ciprofloxacin in Ciprofloxacin Hydrochloride Tablets.