高效液相色谱法同时测定原料药样品及剂型中的希帕胺、氨苯蝶啶和氢氯噻嗪。

High performance liquid chromatography for simultaneous determination of xipamide, triamterene and hydrochlorothiazide in bulk drug samples and dosage forms.

作者信息

Abd El-Hay Soad S, Hashem Hisham, Gouda Ayman A

出版信息

Acta Pharm. 2016 Mar;66(1):109-18. doi: 10.1515/acph-2016-0022.

DOI:10.1515/acph-2016-0022

Abstract

A novel, simple and robust high-performance liquid chromatography (HPLC) method was developed and validated for simultaneous determination of xipamide (XIP), triamterene (TRI) and hydrochlorothiazide (HCT) in their bulk powders and dosage forms. Chromatographic separation was carried out in less than two minutes. The separation was performed on a RP C-18 stationary phase with an isocratic elution system consisting of 0.03 mol L(-1) orthophosphoric acid (pH 2.3) and acetonitrile (ACN) as the mobile phase in the ratio of 50:50, at 2.0 mL min(-1) flow rate at room temperature. Detection was performed at 220 nm. Validation was performed concerning system suitability, limits of detection and quantitation, accuracy, precision, linearity and robustness. Calibration curves were rectilinear over the range of 0.195-100 μg mL(-1) for all the drugs studied. Recovery values were 99.9, 99.6 and 99.0 % for XIP, TRI and HCT, respectively. The method was applied to simultaneous determination of the studied analytes in their pharmaceutical dosage forms.

摘要

开发并验证了一种新颖、简单且稳健的高效液相色谱（HPLC）方法，用于同时测定西帕胺（XIP）、氨苯蝶啶（TRI）和氢氯噻嗪（HCT）原料药及其剂型中的含量。色谱分离在不到两分钟内完成。分离在RP C-18固定相上进行，采用等度洗脱系统，流动相为0.03 mol L(-1)正磷酸（pH 2.3）和乙腈（ACN），比例为50:50，室温下流速为2.0 mL min(-1)。检测波长为220 nm。对系统适用性、检测限和定量限、准确度、精密度、线性和稳健性进行了验证。所有研究药物的校准曲线在0.195 - 100 μg mL(-1)范围内呈线性。XIP、TRI和HCT的回收率分别为99.9%、99.6%和99.0%。该方法用于同时测定所研究分析物在其药物剂型中的含量。