反相高效液相色谱法同时测定散装和胶囊中哌醋甲酯和哌醋甲酯的分析验证和稳定性研究

IF 0.7 Q4 CHEMISTRY, ANALYTICAL Methods and Objects of Chemical Analysis Pub Date : 2022-01-01 DOI:10.17721/moca.2022.99-105
Hathibelagal Mundarinti Sudheer Kumar, Kothapalli Bannoth Chandrasekhar
{"title":"反相高效液相色谱法同时测定散装和胶囊中哌醋甲酯和哌醋甲酯的分析验证和稳定性研究","authors":"Hathibelagal Mundarinti Sudheer Kumar, Kothapalli Bannoth Chandrasekhar","doi":"10.17721/moca.2022.99-105","DOIUrl":null,"url":null,"abstract":"A stability-indicating RP-HPLC method for the simultaneous determination of Serdexmethylphenidate (SER) and Dexmethylphenidate (DEX) has been developed and validated in bulk and tablet dosage forms. SER and DEX are central nervous system stimulants. This combination is used to treat attention deficit hyperactive disorder. The chromatographic analysis was carried out on a Waters C18 Column with 250mm x 4.6 and a particle size of 5 μm, using an isocratic mobile phase of Phosphate Buffer pH 4.8: Methanol (70:30, v/v) at a flow rate of 0.8 mL/min, and the eluents were monitored at an isosbestic point of 215 nm. Specificity, precision, accuracy, linearity, and robustness of the proposed method were all validated according to ICH standards. Forced degradation studies confirmed the method's stability indicating nature. SER and DEX had retention times of 2.390 and 4.602 min, respectively. The developed technique was found to be specific and accurate. SER linearity was achieved between 90-270 μg/mL, while DEX linearity was obtained between 17.50-52.50 μg/mL. SER had LOD and LOQ of 6.35 and 21.17 μg/mL, whereas DEX had LOD and LOQ of 1.18 and 3.93 μg/mL, respectively. As a result, the suggested HPLC method for the quantification of Serdexmethylphenidate (SER) and Dexmethylphenidate (DEX) was reliable, repeatable, accurate, and sensitive.","PeriodicalId":18626,"journal":{"name":"Methods and Objects of Chemical Analysis","volume":"1 1","pages":""},"PeriodicalIF":0.7000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Analytical Validation and Stability Indicating Studies for Simultaneous Estimation of Serdexmethylphenidate and Dexmethylphenidate by RP-HPLC in Bulk and Capsules\",\"authors\":\"Hathibelagal Mundarinti Sudheer Kumar, Kothapalli Bannoth Chandrasekhar\",\"doi\":\"10.17721/moca.2022.99-105\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A stability-indicating RP-HPLC method for the simultaneous determination of Serdexmethylphenidate (SER) and Dexmethylphenidate (DEX) has been developed and validated in bulk and tablet dosage forms. SER and DEX are central nervous system stimulants. This combination is used to treat attention deficit hyperactive disorder. The chromatographic analysis was carried out on a Waters C18 Column with 250mm x 4.6 and a particle size of 5 μm, using an isocratic mobile phase of Phosphate Buffer pH 4.8: Methanol (70:30, v/v) at a flow rate of 0.8 mL/min, and the eluents were monitored at an isosbestic point of 215 nm. Specificity, precision, accuracy, linearity, and robustness of the proposed method were all validated according to ICH standards. Forced degradation studies confirmed the method's stability indicating nature. SER and DEX had retention times of 2.390 and 4.602 min, respectively. The developed technique was found to be specific and accurate. SER linearity was achieved between 90-270 μg/mL, while DEX linearity was obtained between 17.50-52.50 μg/mL. SER had LOD and LOQ of 6.35 and 21.17 μg/mL, whereas DEX had LOD and LOQ of 1.18 and 3.93 μg/mL, respectively. As a result, the suggested HPLC method for the quantification of Serdexmethylphenidate (SER) and Dexmethylphenidate (DEX) was reliable, repeatable, accurate, and sensitive.\",\"PeriodicalId\":18626,\"journal\":{\"name\":\"Methods and Objects of Chemical Analysis\",\"volume\":\"1 1\",\"pages\":\"\"},\"PeriodicalIF\":0.7000,\"publicationDate\":\"2022-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Methods and Objects of Chemical Analysis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17721/moca.2022.99-105\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Methods and Objects of Chemical Analysis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17721/moca.2022.99-105","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
引用次数: 0

摘要

建立了一种稳定性指示的反相高效液相色谱法(RP-HPLC),用于同时测定原料药和片剂中哌甲酯(SER)和哌甲酯(DEX)的含量。SER和DEX是中枢神经系统兴奋剂。这种组合用于治疗注意缺陷多动障碍。色谱柱为Waters C18,色谱柱尺寸为250mm × 4.6,粒径为5 μm,流动相为磷酸缓冲液pH为4.8:甲醇(70:30,v/v),流速为0.8 mL/min,等吸点为215 nm。该方法的特异性、精密度、准确度、线性和稳健性均按照ICH标准进行验证。强制降解研究证实了该方法的稳定性。SER和DEX的滞留时间分别为2.390 min和4.602 min。所开发的技术被发现是专门和准确的。SER在90 ~ 270 μg/mL之间呈线性关系,DEX在17.50 ~ 52.50 μg/mL之间呈线性关系。SER的LOD和LOQ分别为6.35和21.17 μg/mL, DEX的LOD和LOQ分别为1.18和3.93 μg/mL。结果表明,所建立的高效液相色谱法定量哌甲酯右旋甲酯(SER)和哌甲酯右旋甲酯(DEX)可靠、重复性好、准确、灵敏。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Analytical Validation and Stability Indicating Studies for Simultaneous Estimation of Serdexmethylphenidate and Dexmethylphenidate by RP-HPLC in Bulk and Capsules
A stability-indicating RP-HPLC method for the simultaneous determination of Serdexmethylphenidate (SER) and Dexmethylphenidate (DEX) has been developed and validated in bulk and tablet dosage forms. SER and DEX are central nervous system stimulants. This combination is used to treat attention deficit hyperactive disorder. The chromatographic analysis was carried out on a Waters C18 Column with 250mm x 4.6 and a particle size of 5 μm, using an isocratic mobile phase of Phosphate Buffer pH 4.8: Methanol (70:30, v/v) at a flow rate of 0.8 mL/min, and the eluents were monitored at an isosbestic point of 215 nm. Specificity, precision, accuracy, linearity, and robustness of the proposed method were all validated according to ICH standards. Forced degradation studies confirmed the method's stability indicating nature. SER and DEX had retention times of 2.390 and 4.602 min, respectively. The developed technique was found to be specific and accurate. SER linearity was achieved between 90-270 μg/mL, while DEX linearity was obtained between 17.50-52.50 μg/mL. SER had LOD and LOQ of 6.35 and 21.17 μg/mL, whereas DEX had LOD and LOQ of 1.18 and 3.93 μg/mL, respectively. As a result, the suggested HPLC method for the quantification of Serdexmethylphenidate (SER) and Dexmethylphenidate (DEX) was reliable, repeatable, accurate, and sensitive.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
1.00
自引率
14.30%
发文量
12
期刊介绍: The journal "Methods and objects of chemical analysis" is peer-review journal and publishes original articles of theoretical and experimental analysis on topical issues and bio-analytical chemistry, chemical and pharmaceutical analysis, as well as chemical metrology. Submitted works shall cover the results of completed studies and shall make scientific contributions to the relevant area of expertise. The journal publishes review articles, research articles and articles related to latest developments of analytical instrumentations.
期刊最新文献
Systematic Review and Guidelines for Management of Scrotal Inguinal Hernias. Study of the Biochemical Potential of Wild Fruit of the Caucasus Medar (Mespilus caucasics L.) in the Post-Harvest Period Chromatographic Determination of the Chemical Composition of Apple Chips Extract Development, Optimization, and Validation of a Novel HPLC Method for Simultaneous Quantification of Artesunate and Amodiaquine in Tablet Formulations Analytical Validation of a Reversed-Phase Ion Pairing HPLC-DAD Method for the Simultaneous Determination of Anthropogenic Pollutants
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1