Development and Validation of an Eco-friendly RP-HPLC Method for Vonoprazan: A QbD Approach

IF 1.6 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Chromatographia Pub Date : 2025-09-09 DOI:10.1007/s10337-025-04440-5

P. B. Patil, G. B. Patil, R. V. Sonawane, V. A. Bagul, A. R. Tiwari

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引用次数: 0

Abstract

Aim

This study aimed to develop and validate a chromatography-based analytical method for the quantification of Vonoprazan fumarate in pharmaceutical formulations, minimizing solvent consumption. A single chromatographic condition was optimized using the principles of design of experiments (DoE) and an analytical quality by design (QbD) approach, in compliance with regulatory guidelines.

Methods

The method was validated per ICH guidelines, assessing linearity, system suitability, accuracy, precision, robustness, specificity, solution stability, and filter compatibility. Box–Behnken response surface methodology was employed to optimize critical method parameters (CMPs) based on the analytical target profile. Green analytical tools, including the Green Analytical Procedure Index (GAPI), National Environmental Method Index (NEMI), Analytical GREEnness Metric (AGREE), and Analytical Eco-Scale (AES), were applied to evaluate environmental impact.

Results

The method exhibited excellent linearity (R² = 0.9999) within a working concentration range of 7.5–22.5 µg mL⁻¹. Recovery studies at 50–150% concentrations demonstrated 99–101% accuracy. The assay of Vonoprazan yielded 100.6%, with a retention time of 1.825 min. Intra- and inter-day precision showed relative standard deviations below 2%. Robustness studies confirmed method stability under varied conditions. The Box–Behnken design demonstrated a significant quadratic relationship between CMPs and critical material attributes (CMAs).

Conclusion

The developed HPLC method provides accurate, precise, and specific quantification of Vonoprazan in bulk and formulations. Its excellent recovery, minimal standard deviation, and eco-friendly profile make it suitable for routine pharmaceutical analysis, confirming its reliability and sustainability.

Graphical Abstract

Abstract Image

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Vonoprazan生态友好型反相高效液相色谱法的建立与验证：QbD方法

目的建立并验证一种色谱分析方法，以最大限度地减少溶剂消耗，定量测定制剂中富马酸伏诺哌赞的含量。采用实验设计原则（DoE）和分析质量设计（QbD）方法对单色谱条件进行优化，符合法规要求。方法根据ICH指南对方法进行验证，评估线性度、系统适用性、准确性、精密度、鲁棒性、特异性、溶液稳定性和过滤器兼容性。基于分析目标剖面，采用Box-Behnken响应面法优化关键方法参数（cmp）。采用绿色分析工具，包括绿色分析程序指数（GAPI）、国家环境方法指数（NEMI）、分析绿色度度量（AGREE）和分析生态尺度（AES）来评价环境影响。结果该方法在7.5 ~ 22.5µg mL−1的工作浓度范围内线性良好（R2 = 0.9999）。在50-150%浓度下的回收率研究表明准确度为99-101%。伏诺哌嗪的提取率为100.6%，保留时间为1.825 min。日内、日间精度相对标准偏差小于2%。鲁棒性研究证实了该方法在不同条件下的稳定性。Box-Behnken设计表明，cmp和关键材料属性（cma）之间存在显著的二次关系。结论所建立的高效液相色谱法能准确、精确、专属性地定量伏诺哌嗪的原料药和制剂。其卓越的回收率，最小的标准偏差和环保的特点使其适合常规药物分析，证实了其可靠性和可持续性。图形抽象

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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.