近红外光谱法快速分析注射用头孢呋辛钠的含量

Development of a Near IR Method for Rapid Determination of Cefuroxime Sodium for Injection

目的建立测定注射用头孢呋辛钠含量的近红外光谱(NIR)快速分析方法。方法收集到国内外不同企业生产的注射用头孢呋辛钠样品,为扩大浓度线性范围制备了加速试验样品,用光纤探头抵住包装瓶底直接采集光谱,用偏最小二乘法(PLS)建立了其近红外漫反射定量分析模型,考察了不同建模谱段及校正集样本的选择对模型预测能力的影响。结果所建模型具有较好的预测能力,验证集样品的NIR预测值与参考值间的相关性为97.2%,平均预测偏差为1.0%,预测均方差(RMSEP)为1.40%。结论该法快速、简便、无损伤,满足药品现场快速检查的需要。

OBJECTIVE To develop a near-infrared spectroscopy （NIR）, a nondestructive analytical technique, for the rapid determination of the concentrations of cefuroxime sodium for injection. METHODS By using fiber optic probes,the near-infrared diffuse reflectance spectra of cefuroxime sodium for injection from different pharmaceutical factories collected directly through the bottom of injection sample were obtained without any sample preparation. The partial least squares （PLS） was applied to establish the model, high performance liquid chromatography （HPLC） was the reference method used for this study. RESULTS The model had a good performance for prediction. The value of the correlation coefficient （ r^2 ） was 97. 2% ,the mean difference of prediction for test sets was 1.0%, the root mean square error of prediction（RMSEP） was 1.40%. CONCLUSION NIR is a quick,reliable and powerful method for the quantitation of cefuroxime sodium for injection, and can be applied to drug rapid determination on the spot and study the stability of samples.