In this paper, chromatographic anal

In this paper, chromatographic analysis of active substance olopatadine
hydrochloride, which is used in eye drops as antihistaminic agent, and
its impurity E isomer by hydrophilic interaction liquid chromatography
(HILIC) and application of design of experiments (DoE) methodology
are presented. In addition, benzalkonium chloride is very often used
as a preservative in eye drops. Therefore, the evaluation of its chromatographic
behavior in HILIC was carried out as well. In order to estimate
chromatographic behavior and set optimal chromatographic
conditions, DoE methodology was applied. After the selection of important
chromatographic factors, Box–Behnken design was utilized, and
on the basis of the obtained models factor effects were examined.
Then, multi-objective robust optimization is performed aiming to obtain
chromatographic conditions that comply with several quality criteria
simultaneously: adequate and robust separation of critical peak pair
and maximum retention of the first eluting peak. The optimal conditions
are identified by using grid point search methodology. The experimental
verification confirmed the adequacy of the defined optimal conditions.
Finally, under optimal chromatographic conditions, the method was validated
and applicability of the proposed method was confirmed.

結果 (中文) 1:

在本文中，活性物质奥洛他定的色谱分析盐酸盐，作为在滴眼液抗组胺剂，和亲水作用液相色谱及其杂质 E 异构体(HILIC) 和设计实验 (DoE) 方法中的应用介绍了。 此外，非常常用苯扎氯铵作为一种防腐剂滴眼液中。 因此，评价其色谱HILIC 的行为也进行了。 为了估计组分的色谱行为和集优化色谱条件，方法的 DoE。 之后的重要选择色谱的因素，框贝肯设计是利用，和所得模型的基础上考察了因素影响。然后，多目标鲁棒优化执行旨在获得色谱条件的遵守几个质量标准同时︰ 足够和鲁棒性分离的临界峰值双和第一的洗脱峰最大保留。 最优的条件通过使用网格点搜索方法标识。 实验核查证实这些足够定义的最佳条件。最后，在优化的色谱条件下该方法的验证并证实了该方法的适用性。

結果 (中文) 3:

In并paper，chromatographic analysis明确active substance olopatadinehydrochloride，which is used in eye drops as antihistaminic、媒介，and其impurity E isomer by hydrophilic interaction liquid chromatography（HILIC）and application design明确明确experiments（DoE）methodologyare presented . In addition，benzalkonium chloride is very often usedas a preservative in eye drops . Therefore，the evaluation明确其chromatographicbehavior in HILIC was carried out as well . In order to estimatechromatographic behavior and组optimal chromatographicconditions，DoE methodology was applied . After the selection明确importantchromatographic factors，橙盒–Behnken design was utilized，andon the basis明确the obtained models factor effects were examined .Then，multi - objective robust optimization is performed aiming to obtainchromatographic conditions即comply with several质量criteriasimultaneously : adequate and robust separation明确critical peak pairretention and maximum明确the first eluting peak The optimal conditions .are identified by using grid point search methodology The experimental .verification confirmed the adequacy明确the defined optimal conditions .Finally，under optimal chromatographic conditions，the method was validatedand applicability明确the proposed method was confirmed .