利用近红外光谱技术快速鉴别厄贝沙坦分散片

Application in identification of Irbesartan Dispersible Tablets with near-infrared spectroscopy technology

目的应用近红外光谱分析技术和化学计量学方法对厄贝沙坦分散片(A公司)快速鉴别。方法以厄贝沙坦分散片为分析对象,用光纤法测定近红外光谱,通过一致性指数值和CI限度比较法建立一致性检验模型,通过相关系数法建立特征谱段相关系数模型。结果上述两个模型均可快速鉴别并准确区分厄贝沙坦分散片(A公司)与其他生产厂家的同类产品,其他生产厂家验证样品的一致性指数值均大于7.0,与参考样品的相关系数值(R2)均小于97%。结论本方法简便,快速,可用于厄贝沙坦分散片(A公司)的现场快速鉴别。

Objective To develop methods for rapid identification of Irbesartan Dispersible Tablets by Near-infrared（ NIR） spectroscopy analytical technology and chemometrics. Methods NIR spectrum of Irbesartan Dispersible Tablets were collected by a fiber optic probe. The conformity test model was performed by comparing consistency index（ CI） value and CI limit. The quick compare model was established through the correlation coefficient method. Results The conformity test model and quick compare model can rapidly identify and accurately distinguish Irbesartan Dispersible Tablets（ manufactured by A） from similar products of other manufacturers. The CI value of the validation samples from other manufactures beyond the limit of 7. 0. Compared with the reference sample,the correlation coefficient（ R2） were less than 97%. Conclusion The NIR methods were simple and rapid,which can be used in quick identification of Irbesartan Dispersible Tablets（ manufactured by A） in mobile lab.