A Robust and Reliable UPLC Method for the Simultaneous Quantification of Rosuvastatin Calcium, Glibenclamide, and Candesartan Cilexetil

Separations Pub Date : 2024-04-07 DOI:10.3390/separations11040113

M. Ibrahim, Abdelrahman Y. Sherif, D. Alshora, Badr S. Alsaadi

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Abstract

Metabolic syndrome is an associated condition that occurs together and increases the risk of heart disease and diabetes. These conditions include high blood pressure, high blood sugar, and high body mass index (BMI) in terms of cholesterol and triglyceride levels. Most of the elderly population may administer three drugs to control the above conditions. Therefore, this study aims to develop an analytical assay for the precise analysis of three components and to formulate a Self-Nanoemulsifying Drug-Delivery System (SNEDDS) loaded with three drugs: Rosuvastatin Calcium (RC; antilipidemic), Glibenclamide (GB; antidiabetic), and Candesartan Cilexetil (CC; antihypertensive). A design of the experiment was developed at a level of 32, and the influence of column temperature and flow rate was studied in terms of retention time, peak area, peak asymmetry, and resolution. The assay was subjected to several studies to ensure its validation. Under the optimized conditions—column temperature at 50 °C and flow rate at 0.25 mL/min—the three drugs, RC, GB, and CC, are separated. Their retention times are 0.840, 1.800, and 5.803 min, respectively. The assay was valid in terms of linearity, accuracy, and precision. Moreover, the developed assay shows a good tolerance against any change in the condition. The assay was tested also to separate the drugs in a pharmaceutical formulation as SNEDDs. The assay successfully separates the drug with a good resolution.

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用于同时定量检测瑞舒伐他汀钙、格列本脲和坎地沙坦西来替酯的稳定可靠的超高效液相色谱法

代谢综合征是一种同时出现的相关病症，会增加罹患心脏病和糖尿病的风险。这些病症包括高血压、高血糖以及胆固醇和甘油三酯水平方面的高体重指数（BMI）。大多数老年人可能会服用三种药物来控制上述症状。因此，本研究旨在开发一种可精确分析三种成分的分析方法，并配制出一种含有三种药物的自纳米乳化给药系统（SNEDDS）：瑞舒伐他汀钙片（RC；抗血脂药）、格列本脲（GB；抗糖尿病药）和坎地沙坦西来替酯（CC；抗高血压药）。实验设计为 32 级，研究了色谱柱温度和流速对保留时间、峰面积、峰不对称和分辨率的影响。该检测方法经过了多次研究，以确保其有效性。在优化条件下（色谱柱温度为 50 °C，流速为 0.25 mL/min），RC、GB 和 CC 三种药物得以分离。它们的保留时间分别为 0.840、1.800 和 5.803 分钟。该检测方法在线性、准确度和精密度方面均有效。此外，所开发的检测方法对条件的任何变化都有很好的耐受性。该测定法还用于分离药物制剂中的 SNEDDs。该检测方法成功地分离出了药物，并具有良好的分辨率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Separations

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