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<p>Tafamidis is used in the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). It was discovered that the developed Reverse Phase-HPLC method was novel, quick, accurate, and stability-indicating. The drug’s chromatographic analysis was carried out using an isocratic method, and a C18 BPS 250mmx4.6mm5µm column was used to achieve the separation. 40&#xa0;°C was the column’s temperature and 1&#xa0;ml/min was flow rate. The mobile phase consists of 25 mM potassium dihydrogen phosphate buffer of pH 6.5 and acetonitrile solution in a ratio of 50:50% v/v. The analyte was observed at 300&#xa0;nm using methanol as the diluent. The injection. volume was kept 20 <InlineEquation ID="IEq1"> <EquationSource Format="TEX">\(\:\mu\:L\)</EquationSource> </InlineEquation>. Tafamidis was found to have a retention time of roughly 2.48&#xa0;min; therefore, only 5&#xa0;min of runtime is needed. With a correlation coefficient of 0.999, the drug demonstrated linearity in the concentration range of 2.5&#xa0;µg/ml. to 20&#xa0;µg/ml. Tafamidis was found to have Limit of detection and Limit of quantification values of 0.07&#xa0;µg/ml and 0.225&#xa0;µg/ml, respectively. Hence the method is extremely sensitive, as per ICH Q2 (R2) guidelines, the method validation was successfully completed. The drug was subjected to a variety of stress conditions for forced degradation studies. Tafamidis can be routinely analyzed using this method because it is entirely new and time saving because of lesser run time (5&#xa0;min) as compared to existing methods.</p>

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A stability indicating analytical method development and validation of drug Tafamidis using RP-HPLC

  • 期刊论文

  • 发表日期：

    2026年3月18日

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  • Sandhya Shinde,
  • Moreshwar Mahajan

摘要

Tafamidis is used in the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). It was discovered that the developed Reverse Phase-HPLC method was novel, quick, accurate, and stability-indicating. The drug’s chromatographic analysis was carried out using an isocratic method, and a C18 BPS 250mmx4.6mm5µm column was used to achieve the separation. 40 °C was the column’s temperature and 1 ml/min was flow rate. The mobile phase consists of 25 mM potassium dihydrogen phosphate buffer of pH 6.5 and acetonitrile solution in a ratio of 50:50% v/v. The analyte was observed at 300 nm using methanol as the diluent. The injection. volume was kept 20 \(\:\mu\:L\) . Tafamidis was found to have a retention time of roughly 2.48 min; therefore, only 5 min of runtime is needed. With a correlation coefficient of 0.999, the drug demonstrated linearity in the concentration range of 2.5 µg/ml. to 20 µg/ml. Tafamidis was found to have Limit of detection and Limit of quantification values of 0.07 µg/ml and 0.225 µg/ml, respectively. Hence the method is extremely sensitive, as per ICH Q2 (R2) guidelines, the method validation was successfully completed. The drug was subjected to a variety of stress conditions for forced degradation studies. Tafamidis can be routinely analyzed using this method because it is entirely new and time saving because of lesser run time (5 min) as compared to existing methods.