利用质谱建立和验证工作区空气中琥珀酸美托洛尔的高效液相色谱定量检测方法

Alla Yu. Savchenko, Ilya I. Kartamyshev, Pavel A. Zhiltcov, Natalya S. Dubovik
{"title":"利用质谱建立和验证工作区空气中琥珀酸美托洛尔的高效液相色谱定量检测方法","authors":"Alla Yu. Savchenko, Ilya I. Kartamyshev, Pavel A. Zhiltcov, Natalya S. Dubovik","doi":"10.47470/0869-7922-2024-32-1-31-41","DOIUrl":null,"url":null,"abstract":"Introduction. Metoprolol is a cardioselective blocker of β-adrenergic receptors. Drugs containing metoprolol have hypotensive, antianginal, antiarrhythmic effects. Moderately dangerous when taken orally, has a general toxic effect. Metoprolol is produced in two forms: in the form of salts of tartaric and succinic acids, the approximate safe level of exposure to which is 0.3 mg/m3. To ensure the safety of workers, it is necessary to carry out sanitary and hygienic air control. Methods for the quantitative analysis of metoprolol in the air of the working area, presented in the current scientific literature, allow monitoring only for metoprolol salts in the form of tartrate. \nThe aim of the study is to develop and validate an analytical method for the quantitative determination \nof metoprolol succinate in the air of the working area by HPLC-MS. \nMaterials and methods. For the analysis, standard samples of metoprolol succinate and air samples taken at all stages of the life cycle of the production of the drug metoproolol were used. Chromatographic separation and detection were performed on an Agilent 1260 Infinity G6125B high performance liquid chromatograph (Agilent Technologies, USA) equipped with a column and sample thermostat, a degasser, a pump, an autosampler, and a G6125B mass selective detector. A Waters Xbridge® C18 3.5 µm column was used; 2.1×30 mm (Waters, Ireland). Primary data were processed using Open Lab CDS ChemStation Edition (Rev. C.01.07 SR3) software (Agilent Technologies, USA). \nResults. A method for the quantitative determination of metoprolol succinate in air samples by HPLC-MS has been developed and validated. During the validation of the developed methodology, it was found that the validation characteristics (specificity, linearity, accuracy and precision, correctness, reproducibility) are within the acceptance criteria. The analytical range of the technique was 0.1–10.0 µg/ml and allows the developed technique to be used to control the average shift MPCs in the air of the working area. \nLimitations. The results of the study of the air in the working area are applicable only to the production of the drug metoprolol in the form of tablets; the study of air during the synthesis and packaging of the active pharmaceutical substance was not carried out. \nConclusion. An analysis of air samples from the production of the drug metoprolol was carried out and the safety of working conditions was proved.","PeriodicalId":23128,"journal":{"name":"Toxicological Review","volume":"77 6","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development and validation of a method for the quantitative determination of metoprolol succinate in the air of the working area by high-performance liquid chromatography using mass spectra\",\"authors\":\"Alla Yu. Savchenko, Ilya I. Kartamyshev, Pavel A. Zhiltcov, Natalya S. Dubovik\",\"doi\":\"10.47470/0869-7922-2024-32-1-31-41\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction. Metoprolol is a cardioselective blocker of β-adrenergic receptors. Drugs containing metoprolol have hypotensive, antianginal, antiarrhythmic effects. Moderately dangerous when taken orally, has a general toxic effect. Metoprolol is produced in two forms: in the form of salts of tartaric and succinic acids, the approximate safe level of exposure to which is 0.3 mg/m3. To ensure the safety of workers, it is necessary to carry out sanitary and hygienic air control. Methods for the quantitative analysis of metoprolol in the air of the working area, presented in the current scientific literature, allow monitoring only for metoprolol salts in the form of tartrate. \\nThe aim of the study is to develop and validate an analytical method for the quantitative determination \\nof metoprolol succinate in the air of the working area by HPLC-MS. \\nMaterials and methods. For the analysis, standard samples of metoprolol succinate and air samples taken at all stages of the life cycle of the production of the drug metoproolol were used. Chromatographic separation and detection were performed on an Agilent 1260 Infinity G6125B high performance liquid chromatograph (Agilent Technologies, USA) equipped with a column and sample thermostat, a degasser, a pump, an autosampler, and a G6125B mass selective detector. A Waters Xbridge® C18 3.5 µm column was used; 2.1×30 mm (Waters, Ireland). Primary data were processed using Open Lab CDS ChemStation Edition (Rev. C.01.07 SR3) software (Agilent Technologies, USA). \\nResults. A method for the quantitative determination of metoprolol succinate in air samples by HPLC-MS has been developed and validated. During the validation of the developed methodology, it was found that the validation characteristics (specificity, linearity, accuracy and precision, correctness, reproducibility) are within the acceptance criteria. The analytical range of the technique was 0.1–10.0 µg/ml and allows the developed technique to be used to control the average shift MPCs in the air of the working area. \\nLimitations. The results of the study of the air in the working area are applicable only to the production of the drug metoprolol in the form of tablets; the study of air during the synthesis and packaging of the active pharmaceutical substance was not carried out. \\nConclusion. An analysis of air samples from the production of the drug metoprolol was carried out and the safety of working conditions was proved.\",\"PeriodicalId\":23128,\"journal\":{\"name\":\"Toxicological Review\",\"volume\":\"77 6\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-02-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Toxicological Review\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.47470/0869-7922-2024-32-1-31-41\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Toxicological Review","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.47470/0869-7922-2024-32-1-31-41","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

简介美托洛尔是一种β肾上腺素能受体的心脏选择性阻断剂。含有美托洛尔的药物具有降血压、抗心绞痛和抗心律失常的作用。口服时有中度危险,具有一般毒性作用。美托洛尔有两种生产形式:酒石酸盐和琥珀酸盐形式,安全接触浓度约为 0.3 毫克/立方米。为了确保工人的安全,有必要对空气进行卫生控制。目前科学文献中介绍的定量分析工作区空气中美托洛尔的方法只能监测酒石酸盐形式的美托洛尔盐。本研究的目的是开发并验证一种通过 HPLC-MS 对工作区空气中琥珀酸美托洛尔进行定量测定的分析方法。材料和方法。分析使用了琥珀酸美托洛尔的标准样品和美托洛尔药物生产生命周期各个阶段的空气样品。色谱分离和检测在 Agilent 1260 Infinity G6125B 高效液相色谱仪(美国安捷伦科技公司)上进行,该仪器配备有色谱柱和样品恒温器、脱气器、泵、自动进样器和 G6125B 质量选择检测器。使用的是 Waters Xbridge® C18 3.5 µm 色谱柱;2.1×30 毫米(爱尔兰 Waters 公司)。使用 Open Lab CDS ChemStation Edition (Rev. C.01.07 SR3) 软件(安捷伦科技,美国)处理原始数据。结果建立并验证了利用 HPLC-MS 对空气样品中琥珀酸美托洛尔进行定量测定的方法。在对所开发方法进行验证的过程中发现,验证特征(特异性、线性、准确度和精密度、正确性、重现性)均在接受标准范围内。该技术的分析范围为 0.1-10.0 微克/毫升,可用于控制工作区空气中的多氯联苯平均转移量。局限性。工作区空气的研究结果仅适用于片剂形式的药物美托洛尔的生产;未对活性药物的合成和包装过程中的空气进行研究。结论对生产药物美托洛尔的空气样本进行了分析,证明了工作条件的安全性。
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 a method for the quantitative determination of metoprolol succinate in the air of the working area by high-performance liquid chromatography using mass spectra
Introduction. Metoprolol is a cardioselective blocker of β-adrenergic receptors. Drugs containing metoprolol have hypotensive, antianginal, antiarrhythmic effects. Moderately dangerous when taken orally, has a general toxic effect. Metoprolol is produced in two forms: in the form of salts of tartaric and succinic acids, the approximate safe level of exposure to which is 0.3 mg/m3. To ensure the safety of workers, it is necessary to carry out sanitary and hygienic air control. Methods for the quantitative analysis of metoprolol in the air of the working area, presented in the current scientific literature, allow monitoring only for metoprolol salts in the form of tartrate. The aim of the study is to develop and validate an analytical method for the quantitative determination of metoprolol succinate in the air of the working area by HPLC-MS. Materials and methods. For the analysis, standard samples of metoprolol succinate and air samples taken at all stages of the life cycle of the production of the drug metoproolol were used. Chromatographic separation and detection were performed on an Agilent 1260 Infinity G6125B high performance liquid chromatograph (Agilent Technologies, USA) equipped with a column and sample thermostat, a degasser, a pump, an autosampler, and a G6125B mass selective detector. A Waters Xbridge® C18 3.5 µm column was used; 2.1×30 mm (Waters, Ireland). Primary data were processed using Open Lab CDS ChemStation Edition (Rev. C.01.07 SR3) software (Agilent Technologies, USA). Results. A method for the quantitative determination of metoprolol succinate in air samples by HPLC-MS has been developed and validated. During the validation of the developed methodology, it was found that the validation characteristics (specificity, linearity, accuracy and precision, correctness, reproducibility) are within the acceptance criteria. The analytical range of the technique was 0.1–10.0 µg/ml and allows the developed technique to be used to control the average shift MPCs in the air of the working area. Limitations. The results of the study of the air in the working area are applicable only to the production of the drug metoprolol in the form of tablets; the study of air during the synthesis and packaging of the active pharmaceutical substance was not carried out. Conclusion. An analysis of air samples from the production of the drug metoprolol was carried out and the safety of working conditions was proved.
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
Toxic pollution: current aspects of plastic waste management, optimal solutions without prohibitive measures usage Mass hydrogen sulfide poisoning and the role of forensic medical examination in proving Development and validation of a method for the quantitative determination of metoprolol succinate in the air of the working area by high-performance liquid chromatography using mass spectra Effect of subchronic use of unsymmetrical dimethylhydrazine on contractile activity of isolated lymphatic vessels Assessment and classification of the danger of endocrine disruptors
×
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