双除数比光谱导数法同时测定片剂中替米沙坦、氯噻酮和西尼地平含量的建立与验证

D. Patel, Pinkal Patel, Janki Patel
{"title":"双除数比光谱导数法同时测定片剂中替米沙坦、氯噻酮和西尼地平含量的建立与验证","authors":"D. Patel, Pinkal Patel, Janki Patel","doi":"10.35652/igjps.2021.111001","DOIUrl":null,"url":null,"abstract":": Aim: Development and Validation of Double Divisor Ratio Spectra Derivative Method for Simultaneous Estimation of Telmisartan, Chlorthalidone and Cilnidipine in Tablet Dosage Form. Method: A new method was developed for the simultaneous quantification of ternary mixtures by double divisor spectra method and validated as per International Conference on Harmonization [(ICH) Q2 (R1)] guideline. In double divisor spectra method absorption spectrum of ternary mixture divided by two of the three compounds in the mixture. Methanol used as solvent for this method. Calibration graphs were established in the range 10-50 μg/mL for Telmisartan, 7.5-17.5 μg/mL for Chlorthalidone and 5-25 μg/mL for Cilnidipine. Results: all the drugs exhibited good linearity over the reported concentration range with acceptable correlation coefficient. The method was validated according to ICH guideline parameters such as accuracy, repeatability, reproducibility showing acceptable percent relative standard deviation of less than 2. Conclusion: The proposed method demonstrated that the method is accurate, simple, precise, compounds not interference with each other and no any prior separation of compounds. © 2020 iGlobal Research and Publishing Foundation.","PeriodicalId":13366,"journal":{"name":"Indo Global Journal of Pharmaceutical Sciences","volume":"89 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"4","resultStr":"{\"title\":\"Development and Validation of Double Divisor Ratio Spectra Derivative Method for Simultaneous Estimation of Telmisartan, Chlorthalidone and Cilnidipine in Tablet Dosage Form\",\"authors\":\"D. Patel, Pinkal Patel, Janki Patel\",\"doi\":\"10.35652/igjps.2021.111001\",\"DOIUrl\":null,\"url\":null,\"abstract\":\": Aim: Development and Validation of Double Divisor Ratio Spectra Derivative Method for Simultaneous Estimation of Telmisartan, Chlorthalidone and Cilnidipine in Tablet Dosage Form. Method: A new method was developed for the simultaneous quantification of ternary mixtures by double divisor spectra method and validated as per International Conference on Harmonization [(ICH) Q2 (R1)] guideline. In double divisor spectra method absorption spectrum of ternary mixture divided by two of the three compounds in the mixture. Methanol used as solvent for this method. Calibration graphs were established in the range 10-50 μg/mL for Telmisartan, 7.5-17.5 μg/mL for Chlorthalidone and 5-25 μg/mL for Cilnidipine. Results: all the drugs exhibited good linearity over the reported concentration range with acceptable correlation coefficient. The method was validated according to ICH guideline parameters such as accuracy, repeatability, reproducibility showing acceptable percent relative standard deviation of less than 2. Conclusion: The proposed method demonstrated that the method is accurate, simple, precise, compounds not interference with each other and no any prior separation of compounds. © 2020 iGlobal Research and Publishing Foundation.\",\"PeriodicalId\":13366,\"journal\":{\"name\":\"Indo Global Journal of Pharmaceutical Sciences\",\"volume\":\"89 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indo Global Journal of Pharmaceutical Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.35652/igjps.2021.111001\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indo Global Journal of Pharmaceutical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.35652/igjps.2021.111001","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 4

摘要

目的:建立双除数比光谱导数法同时测定片剂剂型中替米沙坦、氯噻酮和西尼地平的含量并进行验证。方法:根据国际协调会议[(ICH) Q2 (R1)]指南,建立了双因子谱法同时定量三元混合物的新方法。在双因子光谱法中,三元混合物的吸收光谱除以混合物中三种化合物中的两种。该方法采用甲醇作为溶剂。替米沙坦10 ~ 50 μg/mL、氯噻酮7.5 ~ 17.5 μg/mL、西尼地平5 ~ 25 μg/mL范围内建立校准图。结果:所有药物在报告的浓度范围内线性良好,相关系数可接受。根据ICH指南的准确度、重复性、再现性等参数对方法进行验证,结果显示可接受的相对标准偏差小于2。结论:该方法准确、简便、精密度高,化合物间互不干扰,不存在预先分离现象。©2020全球研究与出版基金会。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of Double Divisor Ratio Spectra Derivative Method for Simultaneous Estimation of Telmisartan, Chlorthalidone and Cilnidipine in Tablet Dosage Form
: Aim: Development and Validation of Double Divisor Ratio Spectra Derivative Method for Simultaneous Estimation of Telmisartan, Chlorthalidone and Cilnidipine in Tablet Dosage Form. Method: A new method was developed for the simultaneous quantification of ternary mixtures by double divisor spectra method and validated as per International Conference on Harmonization [(ICH) Q2 (R1)] guideline. In double divisor spectra method absorption spectrum of ternary mixture divided by two of the three compounds in the mixture. Methanol used as solvent for this method. Calibration graphs were established in the range 10-50 μg/mL for Telmisartan, 7.5-17.5 μg/mL for Chlorthalidone and 5-25 μg/mL for Cilnidipine. Results: all the drugs exhibited good linearity over the reported concentration range with acceptable correlation coefficient. The method was validated according to ICH guideline parameters such as accuracy, repeatability, reproducibility showing acceptable percent relative standard deviation of less than 2. Conclusion: The proposed method demonstrated that the method is accurate, simple, precise, compounds not interference with each other and no any prior separation of compounds. © 2020 iGlobal Research and Publishing Foundation.
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
自引率
0.00%
发文量
0
×
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
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
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 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信