Stanisz Beata, Regulska Katarzyna
Poznan University of Medical Sciences, Department of Pharmaceutical Chemistry, 6 Grunwaldzka St., 60-780 Poznań, Poland.
Acta Pol Pharm. 2013 Jul-Aug;70(4):737-42.
This study investigates the impact of relative air humidity and temperature on the stability of imidapril hydrochloride (IMD) tablets. For this purpose the forced degradation test was used and the following environmental conditions were employed: RH = 76.4% and the temperature range of 313 - 333 K. For the determination of IMD content in the analyzed samples a reversed-phase high performance liquid chromatography (RP-HPLC) technique was used. Three series of tablets were prepared: whole-blistered tablets, whole-bare tablets and halved-bare tablets, in order to analyze the influence of different in-home storage habits on IMD tablets' quality. In the course of the study, the degradation of IMD was observed in each series of tablets. The kinetic mechanisms and the thermodynamic parameters of these reactions were established. It was evidenced that halved IMD tablets stored without immediate packaging retain their quality only for 12 days while tablets stored according to label recommendations are stable for 513 days.
本研究考察了相对空气湿度和温度对盐酸咪达普利（IMD）片剂稳定性的影响。为此，采用了强制降解试验，并采用了以下环境条件：相对湿度 = 76.4%，温度范围为313 - 333 K。为了测定分析样品中IMD的含量，使用了反相高效液相色谱（RP-HPLC）技术。制备了三组片剂：整泡罩片剂、整裸片剂和半裸片剂，以分析不同家庭储存习惯对IMD片剂质量的影响。在研究过程中，在每组片剂中均观察到了IMD的降解。确定了这些反应的动力学机制和热力学参数。结果表明，未立即包装储存的半片IMD片剂仅在12天内保持其质量，而按照标签建议储存的片剂在513天内是稳定的。
