Department of Analytical Chemistry, Faculty of Pharmacy, Bezmialem Vakif University, Fatih, 34093 Istanbul, Turkey.
J Anal Methods Chem. 2013;2013:179627. doi: 10.1155/2013/179627. Epub 2013 Mar 24.
A simple, rapid, and selective HPLC-UV method was developed for the determination of antihypertensive drug substances: amlodipine besilat (AML), olmesartan medoxomil (OLM), valsartan (VAL), and hydrochlorothiazide (HCT) in pharmaceuticals and plasma. These substances are mostly used as combinations. The combinations are found in various forms, especially in current pharmaceuticals as threesome components: OLM, AML, and HCT (combination I) and AML, VAL, and HCT (combination II). The separation was achieved by using an RP-CN column, and acetonitrile-methanol-10 mmol orthophosphoric acid pH 2.5 (7 : 13 : 80, v/v/v) was used as a mobile phase; the detector wavelength was set at 235 nm. The linear ranges were found as 0.1-18.5 μ g/mL, 0.4-25.6 μ g/mL, 0.3-15.5 μ g/mL, and 0.3-22 μ g/mL for AML, OLM, VAL, and HCT, respectively. In order to check the selectivity of the method for pharmaceutical preparations, forced degradation studies were carried out. According to the validation studies, the developed method was found to be reproducible and accurate as shown by RSD ≤6.1%, 5.7%, 6.9%, and 4.6% and relative mean error (RME) ≤10.6%, 5.8%, 6.5%, and 6.8% for AML, OLM, VAL, and HCT, respectively. Consequently, the method was applied to the analysis of tablets and plasma of the patients using drugs including those substances.
建立了一种简单、快速和选择性的 HPLC-UV 方法，用于测定抗高血压药物物质：氨氯地平贝那普利（AML）、奥美沙坦酯（OLM）、缬沙坦（VAL）和氢氯噻嗪（HCT）在药物和血浆中的含量。这些物质主要作为组合使用。这些组合有多种形式，特别是在当前的药物中，它们是三种成分的组合：OLM、AML 和 HCT（组合 I）和 AML、VAL 和 HCT（组合 II）。分离是通过使用 RP-CN 柱实现的，乙腈-甲醇-10mmol 正磷酸 pH 2.5（7：13：80，v/v/v）作为流动相；检测波长设定为 235nm。AML、OLM、VAL 和 HCT 的线性范围分别为 0.1-18.5μg/mL、0.4-25.6μg/mL、0.3-15.5μg/mL 和 0.3-22μg/mL。为了检查该方法对药物制剂的选择性，进行了强制降解研究。根据验证研究，发现所开发的方法具有重现性和准确性，RSD 分别为≤6.1%、5.7%、6.9%和 4.6%，相对平均误差（RME）分别为≤10.6%、5.8%、6.5%和 6.8%，用于 AML、OLM、VAL 和 HCT。因此，该方法应用于包括这些物质的药物的片剂和患者血浆的分析。
