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采用反相高效液相色谱法(RP-HPLC)对含有氢氯噻嗪的三种血管紧张素II受体拮抗剂片剂制剂进行定量测定。

Quantitative Determination of three Angiotensin-II-receptor Antagonists in Presence of Hydrochlorothiazide by RP-HPLC in their Tablet Preparations.

作者信息

Hafez Hany Mohammed, Elshanawane Abdullah Ahmed, Abdelaziz Lobna Mohammed, Kamal Magda Mohammed

机构信息

Medicinal Chemistry Department Faculty of Pharmacy, Zagazig University, Zagazig, Egypt. Chemistry, Nancy University, France, QC Manager, EIPICO, 10 Ramadan, Egypt.

出版信息

Iran J Pharm Res. 2013 Fall;12(4):635-43.

Abstract

Losartan potassium, Valsartan , Telmisartan and Irbesartan are angiotensin-II-receptor antagonists (ARA II) group which used in treatment of hypertension alone or in combination with other drugs mainly Hydrochlorothiazide. RP- HPLC method was developed for the assay of three angiotensin-II-receptor antagonists (ARA-IIs) in presence of Hydrochlorothiazide. The method was performed by reversed phase high performance liquid chromatography using a mobile phase which is consisted of 0.025 M potassium dihydrogen phosphate (pH 6.0): acetonitrile = 65:35% with detection at 220 nm on an ACE C18 column (250 mm × 4.6 mm, 5 μm) at flow rate 1.5 mL/min in an isocratic manner. The proposed method was validated according to ICH guidline in terms of linearity, accuracy, precision , robustness, limit of detection and limit of quantitation.

摘要

氯沙坦钾、缬沙坦、替米沙坦和厄贝沙坦属于血管紧张素 II 受体拮抗剂(ARA II)类药物,可单独用于治疗高血压,或与其他药物(主要是氢氯噻嗪)联合使用。建立了 RP - HPLC 法用于在氢氯噻嗪存在的情况下测定三种血管紧张素 II 受体拮抗剂(ARA - IIs)。该方法采用反相高效液相色谱法,流动相由 0.025 M 磷酸二氢钾(pH 6.0):乙腈 = 65:35% 组成,在 ACE C18 柱(250 mm × 4.6 mm,5 μm)上于 220 nm 处检测,流速为 1.5 mL/min,采用等度洗脱方式。根据 ICH 指南,对所提出的方法在线性、准确度、精密度、稳健性、检测限和定量限方面进行了验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6645/3920712/baf69c88660c/ijpr-12-635-g001.jpg

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