紫外分光光度法和液相色谱法测定头孢匹罗原料药和药量的方法建立与验证

T. P. Oppe, Júlia Menegola, E. Schapoval
{"title":"紫外分光光度法和液相色谱法测定头孢匹罗原料药和药量的方法建立与验证","authors":"T. P. Oppe, Júlia Menegola, E. Schapoval","doi":"10.22456/2527-2616.93809","DOIUrl":null,"url":null,"abstract":"In the present work, analytical methods, UV Spectrophotometry and Liquid Chromatography (HPLC), were developed and validated for quantification of cefpirome, a broad-spectrum fourth-generation cephalosporin, in raw material and powder for injectable preparation. The UV spectrophotometric method was performed at 271 nm, using 0.1 M hydrochloric acid as solvent. The HPLC was carried out using Techsphere ODS column and mobile phase consisted of methanol-water (30:70, v/v) with flow rate 0.8 mL/min and UV detection at 265 nm. The validation method yielded good results demonstrated statistically that the methods were linear, precise, accurate, specific and robust. A preliminary stability study of cefpirome showed that the UV Spectrophotometry and Liquid Chromatography methods were specific for the determination cefpirome in the presence of its degradation products. No statistically difference was observed between the proposed methods. The UV Spectrophotometry and Liquid Chromatography methods allow the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control. ","PeriodicalId":11314,"journal":{"name":"Drug Analytical Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2019-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"6","resultStr":"{\"title\":\"DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRY AND LIQUID CHROMATOGRAPHY METHODS FOR DETERMINATION OF CEFPIROME IN RAW MATERIAL AND PHARMACEUTICAL DOSAGE\",\"authors\":\"T. P. Oppe, Júlia Menegola, E. Schapoval\",\"doi\":\"10.22456/2527-2616.93809\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"In the present work, analytical methods, UV Spectrophotometry and Liquid Chromatography (HPLC), were developed and validated for quantification of cefpirome, a broad-spectrum fourth-generation cephalosporin, in raw material and powder for injectable preparation. The UV spectrophotometric method was performed at 271 nm, using 0.1 M hydrochloric acid as solvent. The HPLC was carried out using Techsphere ODS column and mobile phase consisted of methanol-water (30:70, v/v) with flow rate 0.8 mL/min and UV detection at 265 nm. The validation method yielded good results demonstrated statistically that the methods were linear, precise, accurate, specific and robust. A preliminary stability study of cefpirome showed that the UV Spectrophotometry and Liquid Chromatography methods were specific for the determination cefpirome in the presence of its degradation products. No statistically difference was observed between the proposed methods. The UV Spectrophotometry and Liquid Chromatography methods allow the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control. \",\"PeriodicalId\":11314,\"journal\":{\"name\":\"Drug Analytical Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-07-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Analytical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.22456/2527-2616.93809\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Analytical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.22456/2527-2616.93809","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 6

摘要

本文建立了第四代广谱头孢菌素头孢匹罗的定量分析方法——紫外分光光度法和液相色谱法。以0.1 M盐酸为溶剂,在271 nm波长下进行紫外分光光度法。HPLC柱为Techsphere ODS,流动相为甲醇-水(30:70,v/v),流速为0.8 mL/min,紫外检测波长为265 nm。验证结果表明,该方法具有良好的线性、精密度、准确度、专属性和鲁棒性。对头孢匹罗的稳定性进行了初步研究,结果表明紫外分光光度法和液相色谱法对头孢匹罗降解产物的测定具有特异性。不同方法间无统计学差异。紫外分光光度法和液相色谱法可以定量测定头孢匹罗在制剂剂型和原料中的含量,可用于常规质量控制中的药物分析。
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
DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRY AND LIQUID CHROMATOGRAPHY METHODS FOR DETERMINATION OF CEFPIROME IN RAW MATERIAL AND PHARMACEUTICAL DOSAGE
In the present work, analytical methods, UV Spectrophotometry and Liquid Chromatography (HPLC), were developed and validated for quantification of cefpirome, a broad-spectrum fourth-generation cephalosporin, in raw material and powder for injectable preparation. The UV spectrophotometric method was performed at 271 nm, using 0.1 M hydrochloric acid as solvent. The HPLC was carried out using Techsphere ODS column and mobile phase consisted of methanol-water (30:70, v/v) with flow rate 0.8 mL/min and UV detection at 265 nm. The validation method yielded good results demonstrated statistically that the methods were linear, precise, accurate, specific and robust. A preliminary stability study of cefpirome showed that the UV Spectrophotometry and Liquid Chromatography methods were specific for the determination cefpirome in the presence of its degradation products. No statistically difference was observed between the proposed methods. The UV Spectrophotometry and Liquid Chromatography methods allow the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control. 
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
期刊最新文献
Quantitative analysis of pharmaceutical products by spectrophotometry in the infrared region: a practical review Quality evaluation of solid pharmaceutical preparations for veterinary use containing cephalexin Anti-Candida activity of terpenes from Salvia ovalifolia, S. procurrens and S. uliginosa, native to South Brazil Stability-indicating RP-HPLC method applied to the quantification of anti-histaminic drug ebastine in its oral suspension dosage form Development and validation of UV Spectrophotometric method for simultaneous estimation of Efonidipine hydrochloride ethanolate and Chlorthalidone in their synthetic mixture
×
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