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采用导数分光光度法和高效液相色谱法同时测定片剂中盐酸莫昔普利和氢氯噻嗪的含量。

Simultaneous determination of moexipril hydrochloride and hydrochlorothiazide in tablets by derivative spectrophotometric and high-performance liquid chromatographic methods.

作者信息

Ertürk Sidika, Cetin Sevil Müge, Atmaca Sedef

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, 34116, Beyazit, Istanbul, Turkey.

出版信息

J Pharm Biomed Anal. 2003 Oct 15;33(3):505-11. doi: 10.1016/s0731-7085(03)00252-8.

Abstract

Two new simple and selective assay methods have been presented for the binary mixtures of moexipril hydrochloride (MOEX) and hydrochlorothiazide (HCTZ) in pharmaceutical formulations. The first method depends on second-derivative ultraviolet spectrophotometry with zero-crossing measurements at 215 and 234 nm for MOEX and HCTZ, respectively. The assay was linear over the concentration ranges 1.0-11.0 microg ml(-1) for MOEX and 0.5-9.0 microg ml(-1) for HCTZ. The determination limits for MOEX and HCTZ were found to be 1.0 and 0.5 microg ml(-1), respectively; while the detection limits were 0.2 microg ml(-1) for MOEX and 0.1 microg ml(-1) for HCTZ. The second method was based on isocratic reversed-phase liquid chromatography by using a mobile phase acetonitrile-20 mM phosphate buffer (pH 4.0) (50:50, v/v). Lisinopril was used as an internal standard (IS) and the substances were detected at 212 nm. The linearity range for both drugs was 0.5-12.0 microg ml(-1). The determination and detection limits were found to be 0.100 and 0.010 microg ml(-1) for MOEX and 0.025 and 0.005 microg ml(-1) for HCTZ, respectively. The proposed methods were successfully applied to the determination of these drugs in synthetic mixtures and commercially available tablets with a high percentage recovery, good accuracy and precision.

摘要

本文提出了两种新的简单且具选择性的分析方法,用于测定药物制剂中盐酸莫昔普利(MOEX)和氢氯噻嗪(HCTZ)的二元混合物。第一种方法基于二阶导数紫外分光光度法,分别在215和234nm处进行零交叉测量以测定MOEX和HCTZ。该分析方法在MOEX浓度范围为1.0 - 11.0μg ml⁻¹、HCTZ浓度范围为0.5 - 9.0μg ml⁻¹内呈线性。发现MOEX和HCTZ的测定限分别为1.0和0.5μg ml⁻¹;而MOEX的检测限为0.2μg ml⁻¹,HCTZ的检测限为0.1μg ml⁻¹。第二种方法基于等度反相液相色谱法,使用乙腈 - 20mM磷酸盐缓冲液(pH 4.0)(50:50,v/v)作为流动相。赖诺普利用作内标(IS),在212nm处检测这些物质。两种药物的线性范围均为0.5 - 12.0μg ml⁻¹。发现MOEX的测定限和检测限分别为0.100和0.010μg ml⁻¹,HCTZ的测定限和检测限分别为0.025和0.005μg ml⁻¹。所提出的方法已成功应用于合成混合物和市售片剂中这些药物的测定,回收率高、准确度和精密度良好。

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