{"title":"一种新的稳定性指示液相色谱法测定阿戈美拉汀","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":"{\"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}","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
摘要
阿戈美拉汀是一种褪黑激素抗抑郁药。建立了测定制剂中阿戈美拉汀含量的高效液相色谱法。色谱柱为Shimadzu CBM-20A/ 20alite，色谱柱为Zorbax扩展- c18柱(150 mm × 4.6 mm，粒径5µm)，流动相为0.1%甲酸铵与乙腈(40:60,v/v)，流速为0.8 ml/min。阿戈美拉汀经受了酸性、碱性、氧化光解和热降解等应激条件，并根据ICH指南对方法进行了验证。关键词:阿戈美拉汀，反相高效液相色谱，验证，稳定性指示
A New Validated Stability Indicating Liquid Chromatographic Method for the Determination of Agomelatine
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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