El-Masry Amal A, Hammouda Mohammed E A, El-Wasseef Dalia R, El-Ashry Saadia M
Mansoura University, Faculty of Pharmacy, Department of Medicinal Chemistry, Mansoura, Egypt.
Horus University-Egypt (HUE), Faculty of Pharmacy, Department of Pharmaceutical Chemistry, New Damietta, Egypt.
J AOAC Int. 2018 Aug 10. doi: 10.5740/jaoacint.17-0472.
Green solvents such as microemulsion were used in the proposed method because they play a vital role in the analytical method's influence on the environment. A highly sensitive, specific, and validated stability-indicating eco-friendly green microemulsion liquid chromatography (MELC) method was developed for separation of the antihistaminic drug Azelastine HCl (AZL) from its degradation products with application to degradation kinetics. Chromatographic separation was operated on a C column with a microemulsion mobile phase, which consists of 0.1 M sodium dodecyl sulphate, 10% -propanol, 1% -octanol, and 0.3% triethylamine, by using 0.02 M phosphoric acid at pH 3.5 and irbesartan as internal standard. The eluted compounds were monitored at 210 nm with flow rate 1 mL/min at ambient temperature. A linear dependence of the peak area on drug concentration over the concentration range of 0.1 to 25 μg/mL was achieved with an LOD of 0.04 μg/mL and an LOQ of 0.10 μg/mL. Moreover, the proposed method was successfully applied for determination of AZL in eye drops and metered dose nasal inhaler as well as to study the kinetics of alkaline, acidic, neutral, oxidative, and photolytic degradation processes of AZL according to the International Council for Harmonization guidelines. The proposed method could be used as a harmless alternative for quality control analysis of the mentioned drug, without interference from dosage form additives or decomposition products. A highly sensitive stability-indicating eco-friendly green MELC method was developed for the separation of the antihistaminic drug AZL from its degradation products.
在所提出的方法中使用了微乳液等绿色溶剂，因为它们在分析方法对环境的影响方面起着至关重要的作用。开发了一种高灵敏度、特异性且经过验证的稳定性指示型环保绿色微乳液液相色谱（MELC）方法，用于从其降解产物中分离抗组胺药物盐酸氮卓斯汀（AZL），并应用于降解动力学研究。色谱分离在C柱上进行，流动相为微乳液，由0.1M十二烷基硫酸钠、10%丙醇、1%辛醇和0.3%三乙胺组成，使用pH值为3.5的0.02M磷酸，以厄贝沙坦作为内标。在室温下，以1mL/min的流速在210nm处监测洗脱的化合物。在0.1至25μg/mL的浓度范围内，峰面积与药物浓度呈线性关系，检测限为0.04μg/mL，定量限为0.10μg/mL。此外，根据国际协调理事会指南，所提出的方法成功应用于滴眼液和定量鼻喷雾剂中AZL的测定，以及研究AZL的碱性、酸性、中性、氧化和光解降解过程的动力学。所提出的方法可作为上述药物质量控制分析的无害替代方法，不受剂型添加剂或分解产物的干扰。开发了一种高灵敏度的稳定性指示型环保绿色MELC方法，用于从其降解产物中分离抗组胺药物AZL。
