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建立一种新的 UPLC 方法,共同预测一种多组分药物制剂中的四种活性成分。

Development of a novel UPLC approach to co-prediction of four active compounds in a multi-component pharmaceutical preparation.

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Ankara University, 06560 Yenimahalle, Ankara, Turkey.

Department of Analytical Chemistry, Faculty of Pharmacy, Ankara University, 06560 Yenimahalle, Ankara, Turkey; Department of Analytical Chemistry, Faculty of Pharmacy, Ankara Yıldırım Beyazıt University, 06010 Etlik, Keçiören, Ankara, Turkey.

出版信息

J Chromatogr B Analyt Technol Biomed Life Sci. 2024 Jun 1;1240:124159. doi: 10.1016/j.jchromb.2024.124159. Epub 2024 May 18.

Abstract

In this work, a new ultra-performance liquid chromatography method based on photodiode array detection (UPLC-PDA) was first developed for the quantitative analysis of the quaternary mixture of ascorbic acid (AA), paracetamol (PAR), caffeine (CAF) and chlorpheniramine maleate (CPA) in a commercial dosage form. The developed UPLC-PDA method offered a new possibility for the co-determination of four active ingredients in a drug combination with short run time and simple sample preparation. The successful chromatographic separation of the four drugs was performed using a Waters Acquity UPLC BEH C18 column (1.7 µm 2.1 × 100 mm) (Mildford, USA) and a mobile phase consisting of water (12 %), acetonitrile (13 %) and 0.1 M HPO (75 %) at a flow rate of 0.25 mL/min. The validation of the proposed UPLC-PDA approach was verified by analyzing synthetic mixtures, inter- and intra-day experiments, and commercial powder samples and provided satisfactory results.

摘要

在这项工作中,首次开发了一种基于光电二极管阵列检测(UPLC-PDA)的新超高效液相色谱法,用于定量分析市售制剂中抗坏血酸(AA)、对乙酰氨基酚(PAR)、咖啡因(CAF)和马来酸氯苯那敏(CPA)的四元混合物。所开发的 UPLC-PDA 方法为药物联合中四种活性成分的同时测定提供了新的可能性,具有运行时间短和样品制备简单的特点。使用 Waters Acquity UPLC BEH C18 柱(1.7 µm,2.1×100 mm)(美国米尔福德)和由水(12%)、乙腈(13%)和 0.1 M HPO(75%)组成的流动相,以 0.25 mL/min 的流速,成功地对四种药物进行了色谱分离。通过分析合成混合物、日内和日间实验以及商业粉末样品,对所提出的 UPLC-PDA 方法进行了验证,结果令人满意。

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