Scholarlink

<p>This study describes a simple, rapid, sensitive and selective RP-HPLC method for the quantification of daprodustat in bulk and tablet dosage forms. In the study, the stationary phase consisted of a Zorbax SB-C18 (150&#xa0;mm × 4.6&#xa0;mm, 5&#xa0;μm particle size) column, and the mobile phase consisted of a mixture of acetonitrile:distilled water (80:20, v/v) containing 0.1% formic acid. The flow rate was 1.2&#xa0;mL&#xa0;min<sup>−1</sup>, the injection volume was 10&#xa0;μL and the column temperature was set at 30&#xa0;°C. The linearity range of the method was 10–150&#xa0;μg&#xa0;mL<sup>−1</sup> and acceptable precision and accuracy values were obtained for the values in this range. After the developed method was validated according to ICH Q2 (R1) guideline, it was successfully applied to bulk and tablet dosage form preparations of daprodustat. The method has also been successfully applied to forced degradation studies with exposure to various stress conditions, including acid, base, oxidative stress and thermal degradation following ICH Q1B guidelines.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Stability-Indicating RP-HPLC Method for the Quantification of Daprodusdat in Pharmaceutical Formulation

  • 期刊论文

  • 发表日期：

    2025年2月17日

查看全文
  • Hümeyra Funda Vardar,
  • Sıdıka Ertürk Toker

摘要

This study describes a simple, rapid, sensitive and selective RP-HPLC method for the quantification of daprodustat in bulk and tablet dosage forms. In the study, the stationary phase consisted of a Zorbax SB-C18 (150 mm × 4.6 mm, 5 μm particle size) column, and the mobile phase consisted of a mixture of acetonitrile:distilled water (80:20, v/v) containing 0.1% formic acid. The flow rate was 1.2 mL min−1, the injection volume was 10 μL and the column temperature was set at 30 °C. The linearity range of the method was 10–150 μg mL−1 and acceptable precision and accuracy values were obtained for the values in this range. After the developed method was validated according to ICH Q2 (R1) guideline, it was successfully applied to bulk and tablet dosage form preparations of daprodustat. The method has also been successfully applied to forced degradation studies with exposure to various stress conditions, including acid, base, oxidative stress and thermal degradation following ICH Q1B guidelines.