Scholarlink

<p>In this study, a simple, precise, accurate, and sensitive reversed-phase liquid-chromatographic method (RPLC) for the antimycotic drugs climbazole, oxiconazole, and sertaconazole was developed and validated, the compounds were quantified in commercial preparations and their degradation profiles were determined by forced degradation. All chromatographic separations were performed on a Pinnacle DB Cyano (5 μm, 250 × 4.6 mm) column. Acetonitrile–water binary mixture (45:55, v/v) and pH 7.0 was used as mobile phase. System suitability tests were conducted to determine the suitability of the developed method conditions to the reference values and the results were found to be satisfactory. The validation of the developed RPLC method was performed using linearity, selectivity, accuracy, precision, and recovery parameters. Linear concentration ranges were determined for each compound and the correlation coefficients were found to be greater than 0.998. Limit-of-detection and limit-of-quantitation values were calculated for the studied drugs and the sensitivity and selectivity of the method were found to be sufficient. Quantification of the compounds was carried out in the topical creams and commercial shampoos at the determined separation condition. Stress tests (also known as forced degradation) are performed by exposing compounds to extreme conditions in order to determine their degradation profile over a short period of time. Degradation studies under stress conditions play an important role in different processes of development and production of drugs and pharmaceutical products. The results of these studies are used to assess the degradation behaviors of drugs and to validate chromatographic analytical methods. Compounds were subjected to the International Conference of Harmonization- prescribed acidic, alkaline, oxidative, photolytic and thermal stress conditions, and their degradation behaviors were determined successfully. After all stress tests, the highest degradation for all compounds was observed in the oxidative condition. The developed RPLC method was successfully validated and it can be used in the routine analysis of the quantification and degradation of imidazole compounds and their commercial products.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Investigation of Degradation Behavior of Antimycotic Imidazoles under Stress Conditions and Quantification in Commercial Products

  • 期刊论文

  • 发表日期：

    2025年4月1日

查看全文
  • Zehra ÜSTÜN

摘要

In this study, a simple, precise, accurate, and sensitive reversed-phase liquid-chromatographic method (RPLC) for the antimycotic drugs climbazole, oxiconazole, and sertaconazole was developed and validated, the compounds were quantified in commercial preparations and their degradation profiles were determined by forced degradation. All chromatographic separations were performed on a Pinnacle DB Cyano (5 μm, 250 × 4.6 mm) column. Acetonitrile–water binary mixture (45:55, v/v) and pH 7.0 was used as mobile phase. System suitability tests were conducted to determine the suitability of the developed method conditions to the reference values and the results were found to be satisfactory. The validation of the developed RPLC method was performed using linearity, selectivity, accuracy, precision, and recovery parameters. Linear concentration ranges were determined for each compound and the correlation coefficients were found to be greater than 0.998. Limit-of-detection and limit-of-quantitation values were calculated for the studied drugs and the sensitivity and selectivity of the method were found to be sufficient. Quantification of the compounds was carried out in the topical creams and commercial shampoos at the determined separation condition. Stress tests (also known as forced degradation) are performed by exposing compounds to extreme conditions in order to determine their degradation profile over a short period of time. Degradation studies under stress conditions play an important role in different processes of development and production of drugs and pharmaceutical products. The results of these studies are used to assess the degradation behaviors of drugs and to validate chromatographic analytical methods. Compounds were subjected to the International Conference of Harmonization- prescribed acidic, alkaline, oxidative, photolytic and thermal stress conditions, and their degradation behaviors were determined successfully. After all stress tests, the highest degradation for all compounds was observed in the oxidative condition. The developed RPLC method was successfully validated and it can be used in the routine analysis of the quantification and degradation of imidazole compounds and their commercial products.