近红外特征谱段相关系数法检测胶囊剂中添加的盐酸西布曲明

Near Infrared Correlation Coefficient Method with Characteristic Spectral Band for Determination of Illegally Added Sibutramine Hydrochloride in Capsule Preparations

目的利用近红外特征谱段相关系数法对胶囊剂中是否添加盐酸西布曲明进行快速定性分析。方法以盐酸西布曲明化学对照品的近红外光谱为参照光谱,选择特定谱段,根据盐酸西布曲明被掺入胶囊中的起效浓度建立待测样品光谱与参照光谱在该谱段的相似系数阈值,定性判断待测样品是否含有盐酸西布曲明。结果选定7 521.7～5 453.7谱段为特征谱段,设定阈值为95%,用20个含盐酸西布曲明的市售样品进行验证,相关系数大于95%的有17个,占样品总量的85.00%。结论该方法具有较好的预测能力,可作为市场上检测胶囊剂中是否非法添加盐酸西布曲明的快速、有效检查手段。

Objective To adopt the near infrared（NIR） correlation coefficient method for the rapid and qualitative detection of illegally added sibutramine hydrochloride in capsule preparations.Methods With the near infrared spectrum of the chemical reference substance of sibutramine hydrochloride was used as reference spectrum,the specific spectrum was selected.According to the initial concentration in the capsule adding sibutramine hydrochloride,the threshold value of similarity coefficient in this spectral band of the tested sample spectrum and the reference spectrum was established.Whether the tested sample contained sibutramine hydrochloride was qualitatively estimated. Results The spectral band 7 521.7-5 453.7 was selected as the characteristic spectral band.The threshold value was set as 95%.20 sold samples containing sibutramine hydrochloride were used for verification.17 samples had the related coefficient of more than 95%,accounting for 85.00%of the total samples.Conclusion This method has better predictive ability,which may be used as a fast and effective detection method to determine illegally added sibutramine hydrochloride in capsule preparations on market.