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

IF 1.2 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Chromatographia Pub Date : 2025-02-17 DOI:10.1007/s10337-025-04396-6

Hümeyra Funda Vardar, Sıdıka Ertürk Toker

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.

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稳定性指示反相高效液相色谱法定量测定药物制剂中药效学成分

本研究建立了一种简便、快速、灵敏、选择性的反相高效液相色谱法定量测定原料药和片剂达伐他汀的方法。固定相为Zorbax SB-C18 （150 mm × 4.6 mm， 5 μm粒径）柱，流动相为乙腈：含有0.1%甲酸的蒸馏水（80:20,v/v）的混合物。流速为1.2 mL min - 1，进样量为10 μL，柱温为30℃。方法的线性范围为10 ~ 150 μg mL−1，在此范围内得到了可接受的精密度和准确度。根据ICH Q2 （R1）指南对该方法进行验证后，成功应用于达伐他特原料药和片剂制剂。该方法还成功地应用于暴露于各种应激条件下的强制降解研究，包括酸、碱、氧化应激和热降解，遵循ICH Q1B指南。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Chromatographia 化学-分析化学

CiteScore

3.40

自引率

5.90%

发文量

103

审稿时长

2.2 months

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.