{"title":"Stability-Indicating RP-HPLC Method for the Quantification of Daprodusdat in Pharmaceutical Formulation","authors":"Hümeyra Funda Vardar, Sıdıka Ertürk Toker","doi":"10.1007/s10337-025-04396-6","DOIUrl":null,"url":null,"abstract":"<div><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 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<sup>−1</sup>, 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<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></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"88 4","pages":"323 - 330"},"PeriodicalIF":1.2000,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chromatographia","FirstCategoryId":"92","ListUrlMain":"https://link.springer.com/article/10.1007/s10337-025-04396-6","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.
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