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<p>This paper presents an application example of a chemometric method to quantify an active pharmaceutical ingredient (API) using transmission Raman spectroscopy on film-coated mirabegron tablets 25&#xa0;mg, with the aim of providing a better understanding of method development and validation. The primary research question addressed how these methods could be effectively implemented in regulatorily approvable quality testing, which may be utilized for extended periods during the product life-cycle. The study employed a chemometric approach which used partial least squares (PLS) regression to predict API amounts based on transmission Raman spectra. Method development involved preparing design of experiment (DoE) sample sets, acquiring Raman spectra, and conducting conventional reference analysis. Validation was done to assess accuracy, precision, specificity, and robustness. In particular, specificity and robustness were shown to be important to stable operation of the quality test over the long term. These findings indicate that this chemometric method using transmission Raman spectroscopy can significantly streamline API quantification processes while maintaining regulatory compliance.</p>

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Development and Validation of Chemometric Methods for API Quantification: Application of Transmission Raman Spectroscopy to Mirabegron Tablets

  • 期刊论文

  • 发表日期：

    2025年10月17日

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  • Yusuke Higashi,
  • Tomomi Yokoyama,
  • Daisuke Murayama,
  • Takuya Fukatsu,
  • Kei Motonaga

摘要

This paper presents an application example of a chemometric method to quantify an active pharmaceutical ingredient (API) using transmission Raman spectroscopy on film-coated mirabegron tablets 25 mg, with the aim of providing a better understanding of method development and validation. The primary research question addressed how these methods could be effectively implemented in regulatorily approvable quality testing, which may be utilized for extended periods during the product life-cycle. The study employed a chemometric approach which used partial least squares (PLS) regression to predict API amounts based on transmission Raman spectra. Method development involved preparing design of experiment (DoE) sample sets, acquiring Raman spectra, and conducting conventional reference analysis. Validation was done to assess accuracy, precision, specificity, and robustness. In particular, specificity and robustness were shown to be important to stable operation of the quality test over the long term. These findings indicate that this chemometric method using transmission Raman spectroscopy can significantly streamline API quantification processes while maintaining regulatory compliance.