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首页> 外文期刊>RSC Advances >Chemical stability and interactions in a new antihypertensive mixture containing indapamide and dihydralazine using FT-IR, HPLC and LC-MS methods
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Chemical stability and interactions in a new antihypertensive mixture containing indapamide and dihydralazine using FT-IR, HPLC and LC-MS methods

机译：使用FT-IR，HPLC和LC-MS方法在包含吲达帕胺和二肼苯哒嗪的新型降压混合物中的化学稳定性和相互作用

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Indapamide and dihydralazine can be combined in fixed-dose formulations because of their complementary actions against hypertension. On the other hand, combined formulations present the problem of chemical interactions between the active ingredients, e.g. accelerated degradation of constituents or generation of quite new degradation products. Therefore, the main goal of the present study was to examine the chemical stability of indapamide and dihydralazine, as individuals and as a mixture, to detect potent interactions between both constituents, using FT-IR, HPLC and LC-MS methods. It was clearly shown that both drugs degraded more when they were in the mixture, i.e. indapamide was degraded more under high temperature/high humidity while dihydralazine was more sensitive to UV/VIS light. In solutions, indapamide was sensitive to strong acidic and strong alkaline conditions while dihydralazine degraded at pH ≥ 7. Generally, the process of degradation of indapamide and dihydralazine followed first order kinetics. The fastest degradation of both indapamide and dihydralazine was found at pH ≥ 10. Several degradation products of indapamide and dihydralazine were detected and identified by our LC-MS method. Interactions between both drugs were confirmed by detection of new degradation products of indapamide, i.e. 4-chloro-3-sulfamoylbenzamide and 4-chloro-3-(formylsulfamoyl)- N -(2-methyl-2,3-dihydro-1 H -indol-1-yl)benzamide, only in the presence of dihydralazine.
机译：吲达帕胺和二肼苯哒嗪可以对抗高血压，因此可以固定剂量组合使用。另一方面，组合的制剂存在活性成分之间的化学相互作用的问题，例如在药物组合物中。加速成分降解或产生相当新的降解产物。因此，本研究的主要目的是使用FT-IR，HPLC和LC-MS方法检查吲达帕胺和二肼苯哒嗪的化学稳定性，以个体和混合物的形式，检测两种成分之间的强相互作用。清楚地表明，当两种药物在混合物中时，它们的降解程度都更高，即吲达帕胺在高温/高湿度下的降解程度更高，而二肼苯哒嗪对UV / VIS光的敏感性更高。在溶液中，吲达帕胺对强酸性和强碱性条件敏感，而二肼苯哒嗪在pH≥7时降解。通常，吲达帕胺和二肼苯哒嗪的降解过程遵循一级动力学。在pH≥10时，吲达帕胺和二肼苯哒嗪的降解速度最快。通过我们的LC-MS方法检测并鉴定了几种吲达帕胺和二肼苯哒嗪降解产物。通过检测新的吲达帕胺降解产物，即4-氯-3-氨磺酰基苯甲酰胺和4-氯-3-（甲酰基氨磺酰基）-N-（2-甲基-2,3-二氢-1 H-吲哚-1-基）苯甲酰胺，仅在二肼苯哒嗪存在下。

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