近红外光谱法快速分析含甘油开塞露的含量

目的:建立测定含甘油开塞露含量的近红外光谱(NIR)快速分析方法。 方法:收集到国内36个生产企业的含甘油开塞露样品,为扩大浓度线性范围制备了原料药稀释样品。用光纤探头连接液体采样附件进行光谱扫描,用偏最小二乘法(PLS)建立了其近红外透反射定量分析模型。考察了不同光程采样附件对光谱的影响,考察了光谱预处理方法及建模谱段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99.2%,预测均方差(RMSEP)为0.68%。 结论:该法快速、简便、准确,能够满足药品现场快速检查的需要。

Objective: To establish a rapid determination method for the concentrations of glycerine enema by near- infrared spectroscopy(NIR)nondestructive analytical technique. Methods: By using fiber optic probes with liquid sampling accessories,the near-infrared penetrate reflectance spectra of glycerine enema from different pharmaceutical factories were collected.The partial least squares(PLS)were applied to establish the model,and titration was the reference method used for this study. Results: The model had a good performance for prediction.The correlation coefficient(R²)was 99.2%,and the root mean square error of prediction(RMSEP)was 0.68%. Conclusion: It is clearly demonstrated that NIR is a quick,reliable and a powerful method for the quantitation of glycerine enema,which can be applied to drug rapid determination on the spot.

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