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Kinetic study of the alkaline degradation of imidapril hydrochloride using a validated stability indicating HPLC method

机译：使用经验证的稳定性指示HPLC方法对盐酸咪达普利进行碱性降解的动力学研究

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摘要

An aqueous alkaline degradation study was performed for imidapril hydrochloride (IMD) drug in the presence of its degradation products and an isocratic stability indicating method was presented using a HPLC technique. The separations were performed using an ACE Generix 5C8, 150 x 4.6 mm column and a mobile phase consisting of buffer solution (0.1 M potassium dihydrogen phosphate and 0.02 M tetra-N-butyl ammonium hydrogen sulphate of pH = 4.5 with 1 N HCl) and acetonitrile 60 : 40 (v/v). The wavelength of the detector was adjusted at 210 nm. The method showed high sensitivity concerning accuracy, precision, linearity and specificity within the acceptable range from 0.1 to 100 mg mL(-1)e limit of quantification was found to be 0.0211 mg mL(-1) for IMD. The proposed method was used to determine the drug in its pharmaceutical formulation and to investigate the degradation kinetics of the drug's alkaline-stressed sample. The reactions were found to follow a first-order reaction. The activation energy could also be estimated. The optimized stability indicating HPLC method was validated according to ICH guidelines.
机译：在其降解产物存在下，对盐酸咪达普利（IMD）药物进行了碱性水溶液降解研究，并提出了使用HPLC技术的等度稳定性指示方法。分离使用ACE Generix 5C8、150 x 4.6 mm色谱柱和流动相进行，该流动相由缓冲溶液（0.1 M磷酸二氢钾和0.02 M pH = 4.5的四正丁基硫酸氢铵，含1 N HCl）和乙腈60:40（v / v）。将检测器的波长调节为210nm。该方法显示出关于准确性，精密度，线性和特异性的高灵敏度，在0.1至100 mg mL（-1）的可接受范围内。IMD的定量限为0.0211 mg mL（-1）。所提出的方法用于确定药物制剂中的药物，并研究该药物在碱性条件下的降解动力学。发现反应遵循一级反应。还可以估计活化能。根据ICH指南验证了优化的稳定性指示HPLC方法。

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