基于近红外光谱的阿立哌唑片溶出行为研究

Dissolution behavior of aripiprazole tablets based on near infrared spectroscopy

目的建立阿立哌唑片剂溶出行为近红外定量模型,预测片剂的溶出行为。方法采集阿立哌唑片剂近红外光谱,进行溶出度试验,分别于3、6、9、12、15、30 min时测定每片的溶出度,采取卷积平滑方法预处理波段4000.00~4396.90 cm^(−1)和5326.43~12000.00 cm^(−1)的近红外光谱,以偏最小二乘法建立溶出行为模型。结果不同时间点的校正均方根误差(RMSEC)和预测均方根误差(RMSEP)均在8%以下,不同时间点校正相关系数(RC)和预测相关系数(RP)均在0.95以上(6 min的相关系数除外),近红外光谱和各时间点溶出度之间呈现出良好的相关性。结论近红外光谱分析技术能够预测阿立哌唑片剂的溶出行为,为近红外光谱分析技术在线监测片剂质量奠定了理论基础。

Objective To establish a near infrared(NIR)quantitative model for the dissolution behavior of aripiprazole tablets.Methods The NIR spectra of aripiprazole tablets were collected and the dissolution tests were performed to determine the dissolution of each tablet at 3,6,9,12,15 and 30 min.The near infrared spectra regions of 4000.00-4396.90,5326.43-12000.00 cm^(−1) were pretreated by Savitzky-Golay smoothing filter,and the dissolution behavior model was established by partial least squares method.Results The root mean square error of calibration(RMSEC)and the root mean square error of prediction(RMSEP)at different time points were analyzed.RMSEP was lower than 8%.The calibration correlation coefficient(RC)and the prediction correlation coefficient(RP)at different time points were above 0.95(except for the point of 6 min).There was a good correlation between the NIR spectrum and the dissolution at each time point.Conclusion NIR spectroscopy could predict the dissolution behavior of aripiprazole tablets,which lays a foundation for online quality monitoring of tablets by NIR spectroscopy.