近红外光谱法在琥乙红霉素片定量分析中的应用

摘要

运用近红外光谱法对14个厂家22个批次的琥乙红霉素片进行定量分析,包括琥乙红霉素片含量及溶出度的测定。通过偏最小二乘回归方法建立的含量均匀度和溶出度模型相关系数分别达0．99601和0．98189,校正均方根误差分别为0．670和0．575,预测均方根误差为0．646和0．514,与交叉验证均方根误差相近(分别为0．822和0．683)。基于准确性轮廓外部验证的95%的公差区间,样品相对误差低于5%,含量均匀度和溶出度模型的可预测性得到进一步的验证。本研究表明,近红外光谱法能用于琥乙红霉素片含量的测定,同时也能实现对不同厂家琥乙红霉素片溶出度的预测。%A set of quantitative methods based on near infrared( NIR) spectroscopy was established for quantitative determination of active content and the drug dissolution percentage of 22 batches erythromycin ethylsuccinate tablets from 14 manufacturers. The con-tent and dissolution models were developed by partial least square regression method with good correlation coefficient(R)0. 99601 and 0. 98189 respectively,the root mean square error of calibration values are 0. 670 and 0. 575 respectively,the root mean square error of prediction are 0. 646 and 0. 514 respectively,which are all close to the root mean square error of cross validation(0. 822 and 0. 683 respectively). Based on the 95%tolerance intervals and the relative error below ±5%,the accuracy profile obtained from the external validations further demonstrated good predictability for both the content and dissolution model. This research shows that NIR spectroscopy is able to be used for the determination of the active content,which was successfully applied to predict dissolution rate of tablets from different manufactures of erythromycin ethylsuccinate tablets.