Development and validation of RPLC method for the simultaneous analysis of ACE inhibitors in tablet formulations

Erdem Kuzucanli, Ebru Çubuk Demiralay, Y. D. Daldal, Z. Üstün, İlkay Konçe, Abbase Güleren Alsancak
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引用次数: 2

Abstract

Hypertension is a disease that can progress for many years without symptoms or complications. This disease can cause death and permanent damage to vital organs such as the kidney, heart, and brain. However, when hypertension is treated effectively, these risk factors may decrease significantly. Although many antihypertensive drugs are used in the treatment of hypertension, ACE inhibitors are a new class among these drugs, and their separation and quantitative determinations are important for the success of preclinical, biopharmaceutical, and clinical studies. For this reason, in this study, the simultaneous determination of cilazapril, benazepril, and quinapril from ACE inhibitors, the validation of the developed method, and the quantitative determination of commercial drug dosage forms are aimed. To obtain the optimum liquid chromatographic separation condition, a systematic approach based on the relationship between mobile phase pH and retention time was used. The mobile phase organic modified concentration and column temperature parameters, which are known to affect the retention times of the compounds, were kept constant. When deciding on these parameters, few experiments were carried out.
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片剂中ACE抑制剂的RPLC同步分析方法的建立与验证
高血压是一种可以发展多年而没有症状或并发症的疾病。这种疾病会导致死亡,并对肾脏、心脏和大脑等重要器官造成永久性损伤。然而,当高血压得到有效治疗时,这些危险因素可能会显著减少。虽然许多降压药用于治疗高血压,但ACE抑制剂是其中的一类新药物,其分离和定量测定对于临床前、生物制药和临床研究的成功至关重要。因此,本研究旨在同时测定ACE抑制剂中西拉普利、贝那普利和喹奈普利的含量,验证所建立的方法,并定量测定市售药物剂型。采用基于流动相pH值与保留时间关系的系统方法,确定最佳液相色谱分离条件。流动相有机修饰浓度和柱温参数保持不变,这是已知的影响化合物的保留时间。在确定这些参数时,很少进行实验。
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