{"title":"A New Validated Stability Indicating Liquid Chromatographic Method for the Determination of Agomelatine","authors":"M. M. Annapurna, B. Venkatesh","doi":"10.5530/PHM.2015.6.20","DOIUrl":null,"url":null,"abstract":"Agomelatine is a melatonergic anti-depressant. A stability-indicating high performance liquid chromatographic technique was developed for the determination of Agomelatine in pharmaceutical formulations. Chromatographic separation was achieved on Shimadzu Model CBM-20A/20 Alite, using Zorbax extended-C 18 column (150 mm × 4.6 mm i.d., 5 µm particle size) with a mixture of 0.1% ammonium formate and acetonitrile (40:60, v/v) as mobile phase with a flow rate of 0.8 ml/min. Agomelatine was subjected to stress conditions such as acidic, alkaline, oxidation photolytic and thermal degradations and the method was validated as per ICH guidelines. Key words: Agomelatine, RP-HPLC, Validation, Stability-indicating.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"15 1","pages":"130-136"},"PeriodicalIF":0.0000,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Methods","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5530/PHM.2015.6.20","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 3
Abstract
Agomelatine is a melatonergic anti-depressant. A stability-indicating high performance liquid chromatographic technique was developed for the determination of Agomelatine in pharmaceutical formulations. Chromatographic separation was achieved on Shimadzu Model CBM-20A/20 Alite, using Zorbax extended-C 18 column (150 mm × 4.6 mm i.d., 5 µm particle size) with a mixture of 0.1% ammonium formate and acetonitrile (40:60, v/v) as mobile phase with a flow rate of 0.8 ml/min. Agomelatine was subjected to stress conditions such as acidic, alkaline, oxidation photolytic and thermal degradations and the method was validated as per ICH guidelines. Key words: Agomelatine, RP-HPLC, Validation, Stability-indicating.
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