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首页> 外文期刊>Biomedical Chromatography: An International Journal Devoted to Research in Chromatographic Methodologies and Their Applications in the Biosciences >Simultaneous estimation of six anti-diabetic drugs--glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to hu
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Simultaneous estimation of six anti-diabetic drugs--glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to hu

机译：同时评估六种抗糖尿病药物-格列本脲，格列齐特，格列吡嗪，吡格列酮，瑞格列奈和罗格列酮：一种用于药物制剂分析的新型HPLC方法的开发及其在人中的应用

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摘要

This paper describes a convenient method for the separation and simultaneous determination of six anti-diabetic drugs viz., glibenclamide (GLB), gliclazide (GLC), glipizide (GLZ), pioglitazone (PGL), repaglinide (RPG) and rosiglitazone (RGL) in pharmaceutical formulations. Also, the assay has been shown applied to support quantification of the six anti-diabetic drugs in human plasma. The analytes were either injected directly onto the column after suitable dilution (pharmaceutical formulation analysis) or a simple extraction procedure, using acetonitrile, from human plasma spiked with anti-diabetic drugs and internal standard (IS). Ternary gradient elution at a flow rate of 1 mL/min was employed on an Intertisl ODS 3V column (4.6 x 250 mm, 5 microm) at ambient temperature. The mobile phase consisted of 0.01 m formic acid (pH 3.0), acetonitrile, Milli Q water and methanol. Celecoxib was used as an IS. The six anti-diabetic drugs were monitored at a wavelength of 260 nm. The nominal retention times of RGL, PGL, GLZ, GLC, GLB, IS and RGL were 11.4, 13.3, 14.8, 17.6, 20.78, 22.1 and 25.4 min, respectively. The assay developed for formulation analysis was found to be accurate and precise. The calibration curves ranged from 0.1 to 100 microg/mL for all analytes with the exception of GLB, where the range was 0.3-100 microg/mL. The plasma assay was validated for parameters such as specificity, accuracy and extraction recovery. The proposed method is simple, selective and can be extended for routine analysis of anti-diabetics in pharmaceutical preparations and in biological matrices.
机译：本文介绍了一种方便的方法，用于分离和同时测定6种抗糖尿病药，即格列本脲（GLB），格列齐特（GLC），格列吡嗪（GLZ），吡格列酮（PGL），瑞格列奈（RPG）和罗格列酮（RGL）在药物制剂中。而且，该测定法已显示可用于支持人血浆中六种抗糖尿病药物的定量分析。经过适当稀释（药物制剂分析）后，将分析物直接注射到色谱柱上，或者使用乙腈从掺有抗糖尿病药和内标（IS）的人血浆中使用乙腈进行简单提取。在室温下在Intertisl ODS 3V色谱柱（4.6 x 250 mm，5 microm）上以1 mL / min的流速进行三元梯度洗脱。流动相由0.01 m甲酸（pH 3.0），乙腈，Milli Q水和甲醇组成。塞来昔布用作IS。在260 nm波长下监测了六种抗糖尿病药。 RGL，PGL，GLZ，GLC，GLB，IS和RGL的标称保留时间分别为11.4、13.3、14.8、17.6、20.78、22.1和25.4分钟。发现开发用于制剂分析的测定是准确和精确的。除GLB外，所有分析物的校准曲线范围为0.1至100微克/毫升，其中GLB的范围为0.3-100微克/毫升。验证血浆分析的特异性，准确性和提取回收率等参数。所提出的方法简单，选择性好，可以扩展到药物制剂和生物基质中抗糖尿病药物的常规分析。

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