...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Talanta: The International Journal of Pure and Applied Analytical Chemistry >Active content determination of non-coated pharmaceutical pellets by near infrared spectroscopy: Method development, validation and reliability evaluation
【24h】

Active content determination of non-coated pharmaceutical pellets by near infrared spectroscopy: Method development, validation and reliability evaluation

机译：近红外光谱法测定未包衣药丸的有效成分：方法开发，验证和可靠性评估

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

A robust near infrared (NIR) method able to quantify the active content of pilot non-coated pharmaceutical pellets was developed. A protocol of calibration was followed, involving 2 operators, independent pilot batches of non-coated pharmaceutical pellets and two different NIR acquisition temperatures Prediction models based on Partial Least Squares (PLS) regression were then carried out. Afterwards, the NIR method was fully validated for an active content ranging from 80 to 120% of the usual active content using new independent pilot batches to evaluate the adequacy of the method to its final purpose. Conventional criteria such as the R-2, the Root Mean Square Error of Calibration (RMSEC), the Root Mean Square Error of Prediction (RMSEP) and the number of PLS factors enabled the selection of models with good predictive potential However, such criteria sometimes fail to choose the most fitted for purpose model. Therefore, a novel approach based on accuracy profiles of the validation results was used, providing a visual representation of the actual and future performances of the models. Following this approach, the prediction model using signal pre-treatment Multiplicative Scatter Correction (MSC) was chosen as it showed the best ability to quantify accurately the active content over the 80-120% active content range. The reliability of the NIR method was tested with new pilot batches of non-coated pharmaceutical pellets containing 90 and 110% of the usual active content, with blends of validation batches and industrial batches All those batches were also analyzed by the HPLC reference method and relative errors were calculated: the results showed low relative errors in full accordance with the results obtained during the validation of the method, indicating the reliability of the NIR method and its interchangeability with the HPLC reference method.
机译：开发了一种鲁棒的近红外（NIR）方法，该方法能够定量测定未包衣的试验性药丸的活性成分。遵循校准方案，涉及2个操作员，未包衣的药丸的独立中试批次和两个不同的NIR采集温度，然后进行了基于偏最小二乘（PLS）回归的预测模型。之后，使用新的独立中试批次对NIR方法的有效含量进行了全面验证，其有效含量为通常活性成分的80％至120％，以评估该方法是否达到其最终目的。诸如R-2，校准的均方根误差（RMSEC），预测的均方根误差（RMSEP）和PLS因子数量之类的常规标准使得能够选择具有良好预测潜力的模型。但是，有时此类标准无法选择最适合目的的模型。因此，使用了一种基于验证结果准确性的新颖方法，以可视方式表示模型的实际和未来性能。按照这种方法，选择了使用信号预处理乘积散射校正（MSC）的预测模型，因为它显示出在80-120％的有效成分范围内准确定量有效成分的最佳能力。 NIR方法的可靠性已通过新的中试非包衣药丸的测试进行了测试，这些非包衣药丸的常规活性成分含量分别为90％和110％，以及验证批次和工业批次的混合物，所有这些批次也都通过HPLC参考方法进行了分析，计算出误差：结果表明，相对误差低，完全符合方法验证期间获得的结果，这表明NIR方法的可靠性及其与HPLC参考方法的互换性。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号