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<p>The development of simple to use, cost-effective, accurate, and precise UV spectrophotometry is the objective of this study. Validation characteristics such as specificity, linearity, accuracy, precision, limit of detection, limit of quantification, and robustness were evaluated in accordance with ICH Q2(R1) guidelines. The drug was measured to have the maximum absorbance at a wavelength of 310 nm. The solution remains stable for up to 12 h. The equation <i>y</i> = 0.1724<i>x</i> – 0.0443, with an <i>R</i><sup>2</sup> of 0.9995, was used to demonstrate the linear response for tafamidis concentration ranges of 2–12 μg/mL. It was found that the accuracy ranged from 100–103%. The intraday and interday precision for repeatability fell within the acceptable parameters (&lt;2%). The technique's limit of detection was 0.112 μg/mL and the limit of quantification was 0.34 μg/mL. The proposed validated method can be applied to standard quality control purposes as well as tafamidis analysis in pharmaceutical doses form.</p>

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Spectrophotometric Approach for Quantitative Analysis of a New Transthyretin Stabilizer: Tafamidis

  • 期刊论文

  • 发表日期：

    2025年3月11日

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  • N. Agarwal,
  • R. Patil,
  • S. Sharma

摘要

The development of simple to use, cost-effective, accurate, and precise UV spectrophotometry is the objective of this study. Validation characteristics such as specificity, linearity, accuracy, precision, limit of detection, limit of quantification, and robustness were evaluated in accordance with ICH Q2(R1) guidelines. The drug was measured to have the maximum absorbance at a wavelength of 310 nm. The solution remains stable for up to 12 h. The equation y = 0.1724x – 0.0443, with an R2 of 0.9995, was used to demonstrate the linear response for tafamidis concentration ranges of 2–12 μg/mL. It was found that the accuracy ranged from 100–103%. The intraday and interday precision for repeatability fell within the acceptable parameters (<2%). The technique's limit of detection was 0.112 μg/mL and the limit of quantification was 0.34 μg/mL. The proposed validated method can be applied to standard quality control purposes as well as tafamidis analysis in pharmaceutical doses form.