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Application of supercritical fluid chromatography for separation and quantitation of 15 co‐formulated binary anti‐hypertensive medications using a single elution protocol
Biomedical Chromatography ( IF 1.8 ) Pub Date : 2020-11-23 , DOI: 10.1002/bmc.5035
Pranav A Pandya 1 , Priyanka A Shah 1 , Pranav S Shrivastav 1
Affiliation  

A facile supercritical fluid chromatography method is proposed to analyse 15 co‐formulated binary anti‐hypertensive drug combinations using a customized elution procedure. The effect of mobile phase composition, column back pressure and temperature was suitably optimized for adequate retention, analyte response and resolution. The chromatographic separation of the different drug combinations was performed on a DCPak poly(4‐vinylpyridine) column (250 × 4.6 mm, 5 μm) at 125‐bar pressure and 40°C using a photodiode array detector. A linear gradient of CO2 and 0.1% formic acid in methanol provided the best elution conditions for all drug combinations. Baseline separation of the drugs was possible with resolution factor Rs ranging from 1.42 to 12.58. The method was validated for specificity, sensitivity, accuracy and precision, recovery and robustness. The limit of detection and limit of quantitation for aliskiren, amlodipine, atenolol, candesartan, hydrochlorothiazide, lisinopril, losartan, metoprolol, olmesartan, telmisartan and valsartan were in the range of 0.26–2.56 and 0.77–7.75 μg/mL, respectively. The thermodynamic study revealed that interactions of the drugs with the stationary phase were spontaneous as evident from the negative free energy values, and the separation process was enthalpy driven. The developed method was successfully employed to analyse these drugs in their co‐formulated tablet formulations.

中文翻译:

应用超临界流体色谱法通过单一洗脱方案分离和定量测定15种共配制的二元抗高血压药物

提出了一种简便的超临界流体色谱方法,该方法使用定制的洗脱程序分析15种共同配制的二元抗高血压药物组合。流动相组成,柱背压和温度的影响已得到适当优化,以实现足够的保留,分析物响应和分离度。使用光电二极管阵列检测器在DCPak聚(4-乙烯基吡啶)色谱柱(250×4.6 mm,5μm)上于125 bar压力和40°C下进行色谱分离。CO 2和0.1%甲酸在甲醇中的线性梯度为所有药物组合提供了最佳洗脱条件。使用分辨率因子R s可以基线分离药物从1.42到12.58。验证了该方法的特异性,敏感性,准确性和精密度,回收率和稳健性。阿利吉仑,氨氯地平,阿替洛尔,坎地沙坦,氢氯噻嗪,赖诺普利,氯沙坦,美托洛尔,奥美沙坦,替米沙坦和缬沙坦的检出限和定量限分别在0.26-2.56和0.77-7.75μg/ mL范围内。热力学研究表明,从负自由能值可以明显看出,药物与固定相的相互作用是自发的,并且分离过程是由焓驱动的。所开发的方法已成功地用于分析这些药物在其共同配制的片剂配方中的作用。
更新日期:2020-11-23
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