近红外光谱法快速分析硝酸甘油片的含量

目的: 建立测定硝酸甘油片含量的近红外光谱(NIR)快速分析方法。 方法: 以全国不同企业生产的硝酸甘油片为分析对象,用光纤探头在12000~4000 cm^-1光谱范围内测定近红外漫反射光谱;以校正均方差(RMSEC)和相关系数(R²)为指标,通过筛选,确定了用于建模的最优近红外波段和光谱预处理方法,建立了近红外光谱与HPLC分析值之间的校正模型,并以此预测了15个未知样本。定性鉴别方法为马氏距离与限定值相比较。 结果: 定量模型的浓度范围为0.552%~1.581%g·g^-1,相对标准偏差小于8％,定性鉴别方法可将硝酸甘油片与其他硝酸酯类片剂及安慰剂相区别。 结论: 该方法快速、简便,具有一定的专属性,可用于药物的快速检验。

Objective: NIR method was developed for rapid determination of nitroglycerin tablets. Methods: The diffuse reflectance near-infrared spectra of nitroglycerin tablets from different manufacturers all over the country were determined by a fiber optical probe in 12000-4000 cm^-1.Different wavenumber ranges and spectrum preprocessing methods were investigated according to the root mean square errors of correction(RMSEC)values and the correlation coefficient(R²).This model was developed to correlate the spectra and the values determined by HPLC.The model was successfully applied to predict 15 unknown samples.Comparing the Mahalanbis Distance with the limit value,nitroglycerin tablets were identified. Results: For the quantitative determination,the content range was 0.552％-1.581%g · g^-1,the RSD was less than 8％.The qualitative method has a good specificity to distinguish nitroglycerin tablets from the other antianginal tablets and placebo. Conclusion: The method is simple,rapid,and can be applied to drug rapid determination.