An Analytical Approach by Tri-Combination of Gradient UFLC, Response Surface Methodology and Green Chemistry Principle for Simultaneous Quantification of Azelnidipine and Chlorthalidone in Rabbit Plasma.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of chromatographic science Pub Date : 2025-02-08 DOI:10.1093/chromsci/bmae032

C Bhagyalakshmi, T N Rekha, Piyongsola Longkumer, Koushik Nandan Dutta, Bhargab Jyoti Sahariah, B Ramesh, Manish Majumder

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Abstract

In this study, a sustainable and eco-friendly method is developed to quantify azelnidipine and chlorthalidone in rabbit plasma by gradient liquid chromatography based on green chemistry principle and analytical quality by design. The separation was achieved on a Shim pack C18 (25 cm × 5 cm × 4.6 μm) column with L1 packing. The mobile phase compromised of ethanol and 50-Mm ammonium acetate buffer (pH.6) at flow rate of 0.6 mL/min with 25-min runtime. The resolution and asymmetric factor were identified as critical analytical attributes (CAAs). The screening studies employing Control Noise Experimentation revealed that mobile phase pH, flow rate and ethanol concentration at 6 and 15 min significantly affected the CAAs method. The critical method parameters were optimized using Central Composition design. Chromatogram showed peak of the drugs at retention time of 9.03 min for chlorthalidone and 16.83 min for azelnidipine. The greenness score of the analytical method was found to be 1876.43 using analytical method greenness score calculator. The validation of the developed method was done which showed linearity at the range of 16-520 ng/mL, with R2 of 0.9992 and 0.9996 for azelnidipine and chlorthalidone, respectively, furthermore accuracy, precision, recovery and stability studies are carried out.

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梯度超高效液相色谱法、响应面法和绿色化学原理三结合分析法用于兔血浆中阿折地平与氯沙坦酮的同时定量分析

本研究基于绿色化学原理和分析质量设计，建立了一种梯度液相色谱法定量检测家兔血浆中阿折地平和氯沙坦的可持续和环保型方法。采用 Shim pack C18 (25 cm × 5 cm × 4.6 μm)色谱柱，L1填料。流动相为乙醇和 50-Mm 乙酸铵缓冲液（pH.6），流速为 0.6 mL/min，运行时间为 25 分钟。分辨率和不对称因子被确定为关键分析属性（CAA）。利用控制噪音实验进行的筛选研究表明，流动相的 pH 值、流速以及 6 分钟和 15 分钟的乙醇浓度对 CAAs 方法有显著影响。采用中心组成设计对关键方法参数进行了优化。色谱图显示，氯塞酮的保留时间为 9.03 分钟，阿折地平的保留时间为 16.83 分钟。使用分析方法绿色得分计算器计算出该分析方法的绿色得分为 1876.43。对所开发的方法进行了验证，结果表明该方法在 16-520 纳克/毫升范围内线性关系良好，阿折地平和氯塞酮的 R2 分别为 0.9992 和 0.9996。

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来源期刊

Journal of chromatographic science 化学-分析化学

CiteScore

2.90

自引率

7.70%

发文量

审稿时长

5.6 months

期刊介绍： The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.