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首页> 外文期刊>Open Chemistry >Stress degradation study of two oral antidiabetics, gliclazide and glipizide, and chemical analysis by LC and LC/MS methods
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Stress degradation study of two oral antidiabetics, gliclazide and glipizide, and chemical analysis by LC and LC/MS methods

机译：两种口服降糖药格列齐特和格列吡嗪的应力降解研究以及LC和LC / MS方法的化学分析

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摘要

Kinetic study of degradation of two oral antidiabetics, gliclazide and glipizide, was performed using new HPLC method which was validated in terms of selectivity, sensitivity, linearity, precision and accuracy. The stress degradation was performed in 0.2 M HCl, 0.2 M NaOH as well as in acetate and phosphate buffers over the pH range 3.8–8.3 at 30 and 70°C. In strong acidic and alkaline media gliclazide was almost fully degraded while glipizide showed much higher stability. Generally, degradation processes of gliclazide and glipizide were observed as the first order reactions while the rates of decomposition for both drugs were smallest at pH 8.3. The samples of gliclazide and glipizide stressed in strong acid and alkali at 70°C were additionally analyzed using an LC/MS method and some products of decomposition were detected and identified. It was concluded that glipizide was more resistant to very high or very low pH and would have higher stability compared to gliclazide. Such comparisons have not been performed so far for these valuable drugs. Additional LC/MS study showed that during decomposition of sulfonylureas, different degradation pathways were possible.
机译：使用新的HPLC方法进行了两种口服降糖药格列齐特和格列吡嗪降解的动力学研究，该方法在选择性，灵敏度，线性，精密度和准确性方面均得到验证。在30和70°C下，在pH范围3.8–8.3的0.2 M HCl，0.2 M NaOH以及乙酸盐和磷酸盐缓冲液中进行应力降解。在强酸性和碱性介质中，格列齐特几乎完全降解，而格列吡嗪则显示出更高的稳定性。通常，格列齐特和格列吡嗪的降解过程被视为一级反应，而两种药物的分解速率在pH 8.3时最小。使用LC / MS方法另外分析了在70°C的强酸和强碱下格列齐特和格列吡嗪的样品，并检测和鉴定了一些分解产物。得出的结论是，格列吡嗪比格列齐特对高或低pH值的耐受性更高，并且具有更高的稳定性。到目前为止，尚未对这些有价值的药物进行此类比较。额外的LC / MS研究表明，在磺酰脲分解过程中，可能有不同的降解途径。

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