Prednisolone acetate (PDN) is a corticosteroid anti-inflammatory liable to degradation under different conditions and used with antibiotics in eye drops. Two selective stability-indicating separation techniques were developed for simultaneous determination of PDN and moxifloxacin HCl (MXF) binary mixture in pure forms, ophthalmic formulation, in the presence of PDN impurities and in the presence of their degradation products. The first method was based on HPTLC separation using silica gel 60 F254 HPTLC plates, and a developing system of toluene: ethyl acetate: methanol: ammonia (5.0: 6: 2.0: 0.05, v/v/v/v) is used with detection at 254 nm. The second method was HPLC using a mobile phase of acetonitrile: methanol: deionized water, pH 2.8 (25.0: 35.0: 40.0, v/v/v), at 254 nm. A kinetic study utilizing the developed HPLC method for PDN degradation under different stress conditions was performed. Furthermore, the method was applied for determination in rabbit aqueous humor. Validation was conducted as per ICH guidelines, and system suitability was ascertained. The calibration curves were constructed in the range 0.10-25.00 and 0.20-50.00 μg band-1, for PDN and MXF by HPTLC, while for HPLC, it was 0.02-50.00 and 0.10-50.00 μg mL-1 for both drugs, in order.

中文翻译：

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选择性和灵敏色谱方法，用于测定存在降解产物和潜在杂质的抗菌滴眼液和幽默水溶液中的二元混合物。

醋酸泼尼松龙（PDN）是一种皮质类固醇抗炎药，在不同条件下易于降解，可与滴眼液中的抗生素一起使用。开发了两种选择性的指示稳定性的分离技术，用于在PDN杂质存在及其降解产物存在的同时测定纯净形式，眼科制剂的PDN和莫西沙星盐酸盐（MXF）二元混合物。第一种方法基于使用硅胶60 F254 HPTLC板的HPTLC分离，并使用甲苯：乙酸乙酯：甲醇：氨水（5.0：6：2.0：0.05，v / v / v / v）的显影系统在254nm处。第二种方法是在254 nm下使用乙腈：甲醇：去离子水，pH 2.8（25.0：35.0：40.0，v / v / v）的流动相进行HPLC。使用发达的HPLC方法在不同的应力条件下降解PDN进行了动力学研究。此外，该方法还用于测定兔房水。根据ICH指南进行验证，并确定系统适用性。通过HPTLC对PDN和MXF分别在0.10-25.00和0.20-50.00μgband-1范围内构建校正曲线，而对于HPLC，两种药物的校正曲线分别为0.02-50.00和0.10-50.00μgmL-1 。