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目的:采用近红外漫反射光谱分析技术和化学计量学的方法,建立兰索拉唑片快速、无损的含量测定分析模型。方法:以不同企业生产的兰索拉唑片为分析对象,通过聚类分析方法确定校正集和验证集,光谱处理方法为一阶导数+直线差减法;谱段范围为9746.9~7498.2 cm-1,6101.9~5446.2 cm-1;回归方法为偏最小二乘法(PLS)。结果:142批样品经内部交叉验证建立预测模型,浓度范围为4.72%~17.8%,决定系数(R2)为90.83%,交叉验证均方差(RMSECV)为0.730;用37批样品进行外部验证,外部验证均方差(RMSEP)为0.281,平均相对偏差为2.2%;测定未参与建模的4个厂家10批样品的含量,相对偏差小于3.5%。结论:用本文所建立的分析模型测定含量,结果准确,样品处理简单,可用于药品的现场快速分析。
OBJECTIVE: To establish a rapid and non-destructive determination and analysis model of lansoprazole tablets using near-infrared diffuse reflectance spectroscopy and chemometric methods. Methods: The Lansoprazole tablets produced by different enterprises were analyzed, and the calibration set and validation set were determined by cluster analysis. The spectral processing method was the first derivative + linear subtraction method; the spectral range was 9746.9-7498.2 cm-1 , 6101.9 ~ 5446.2 cm-1; the regression method is partial least squares (PLS). Results: 142 batches of samples were validated by internal cross-validation. The concentration ranged from 4.72% to 17.8%. The coefficient of determination (R2) was 90.83%. The RMSECV was 0.730. External validation was performed with 37 batches of samples. The RMSEP was 0.281 and the average relative deviation was 2.2%. The contents of 10 batches of samples from 4 factories which were not involved in the modeling were less than 3.5%. Conclusion: The analytical model established in this paper, the determination of content, accurate results, sample processing is simple, can be used for rapid field analysis of drugs.