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Novel Stability-Indicating TLC-Densitometric Method for Quantification of Antazoline and Tetryzoline; Application to Pharmaceutical Formulation
Results in Chemistry ( IF 2.5 ) Pub Date : 2023-04-01 , DOI: 10.1016/j.rechem.2023.100920
Ola G. Hussein , Mohamed Abdelkawy , Mamdouh R. Rezk , Dina A. Ahmed , Yasmin Rostom

Ophthalmic pharmaceutical preparation containing antazoline hydrochloride (ANT) and tetryzoline hydrochloride (TET) is prescribed widely as an over the counter (OTC) medication to treatment allergic conjunctivitis and their determination in presence of their degradation products is a major challenge. A novel sensitive, selective, and precise thin-layer chromatographic method established to determination both ANT and TET in both bulk drugs, formulation, and in presence of their degradation products with the elucidation of degradate's structures. Upon using silica gel plates and means of a developing system using ethyl acetate: ethanol: ammonia (8: 2: 0.1, by volume) the studied drugs separation was achieved, and scanning was carried out at 220.0 nm for the separated bands with a 0.2–18.0 µg/band concentration range for each of ANT and TET. Optimum separation was achieved with values Rf of 0.42 and 0.69, for TET and ANT, respectively. Additionally, the studied drugs' stock solutions were imperiled to different stress conditions. Both drugs were found to be vulnerable to alkaline hydrolysis as well as oxidative degradation showing well resolved degradation products' peaks. While they held out against acidic, thermal and photo degradation. Mass spectrometry was employed to elucidate the degradates' structures. Validity was applied for the proposed method with respect to all validation parameters. Effectively the method was applied to estimate the cited drugs' in marketed ophthalmic formulation.



中文翻译:

用于定量安他唑啉和四唑啉的新型稳定性指示薄层光密度法;应用于药物制剂

含有盐酸安他唑啉 (ANT) 和盐酸四唑啉 (TET) 的眼科药物制剂被广泛用作治疗过敏性结膜炎的非处方 (OTC) 药物,在存在降解产物的情况下进行测定是一项重大挑战。建立了一种新的灵敏、选择性和精确的薄层色谱法,用于测定原料药、制剂中的 ANT 和 TET,以及存在其降解产物并阐明降解产物的结构。在使用硅胶板和显影系统时,乙酸乙酯:乙醇:氨水(8:2:0.1,体积比)) 实现了所研究的药物分离,并在 220.0 nm 下对分离的条带进行扫描,ANT 和 TET 的浓度范围为 0.2–18.0 µg/条带。使用值R f实现了最佳分离TET 和 ANT 分别为 0.42 和 0.69。此外,所研究药物的储备溶液会受到不同压力条件的影响。发现这两种药物都容易受到碱水解和氧化降解的影响,显示出降解产物的峰得到很好的解析。虽然它们能抵抗酸、热和光降解。质谱法用于阐明降解物的结构。有效性适用于所有验证参数的拟议方法。该方法有效地应用于估计市售眼科制剂中引用药物的含量。

更新日期:2023-04-05
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