El-Shaheny Rania N, Yamada Koji
Analytical Chemistry Department, Faculty of Pharmacy, Mansoura University.
Anal Sci. 2014;30(6):691-7. doi: 10.2116/analsci.30.691.
The first stability-indicating HPLC method was developed and validated for azelastine HCl (AZL). The separation of AZL from its degradation products was achieved on a C18 column using acetonitrile-0.04 M phosphate buffer of pH 3.5 (32:68, v/v) as a mobile phase with UV-detection at 210 nm and naftazone as an internal standard. The method was rectilinear over the range of 0.2-20.0 μg mL(-1) with a detection limit of 7.05 ng mL(-1). The degradation behavior of AZL was studied under different ICH-recommended stress conditions along with a kinetic investigation; also, degradation products were identified by mass spectrometry. The method was applied for the quality control and stability assessment of AZL in eye drops and nasal spray. The obtained results were favorably compared with those obtained by a comparison method.
开发并验证了首个用于盐酸氮卓斯汀（AZL）的稳定性指示高效液相色谱法。在C18柱上，以乙腈 - 0.04 M pH 3.5的磷酸盐缓冲液（32:68，v/v）作为流动相，在210 nm处进行紫外检测，并以萘他唑啉作为内标，实现了AZL与其降解产物的分离。该方法在0.2 - 20.0 μg mL⁻¹范围内呈线性，检测限为7.05 ng mL⁻¹。在不同的国际协调会议（ICH）推荐的加速条件下研究了AZL的降解行为，并进行了动力学研究；此外，通过质谱鉴定了降解产物。该方法用于滴眼液和鼻喷雾剂中AZL的质量控制和稳定性评估。将所得结果与通过对照方法获得的结果进行了良好的比较。
