中国药物评价2024，Vol.41Issue(2)：101-104,4.
盐酸吡格列酮片中3-硝基吡咯和硫脲的定性定量方法研究
Study on Qualitative and Quantitative Methods of 3-nitropyrrole and Thiourea in Pioglitazone Hydrochloride Tablets
吴月霞 1朱艳春 1陈杰1
作者信息
- 1. 河南省药品医疗器械检验院(河南省疫苗批签中心),河南郑州 450018
- 折叠
摘要
Abstract
Objective:Oestablish a UPLC-MS/MS method for qualitative and quantitative determination of 3-nitropyrrole and thio-urea in pioglitazone hydrochloride tablets.Methods:Waters Cortecs ® T3(2.1 mm × 100 mm,2.7 μm)column was used.The mobile phase A is 0.1％formic acid(V∶V)aqueous solution,and the mobile phase B is 0.1％formic acid(V∶V)acetonitrile so-lution.Gradient elution;Column temperature 30 ℃;Sample size 2 μL;Qualitative and quantitative analysis of 3-nitropyrrole and thiourea was performed by ESI source,positive ion mode and multiple reaction monitoring.Results:3-nitropyrrole and thiourea had a good linear relationship with the peak area in the range of 0.03-0.3 μg·mL-1(r＞0.999 5).The average recoveries were 99.06％-100.26％and RSD was 0.02％-0.46％.The limits of detection were 0.069 3-0.140 7 ng·mL-1,and the limits of quantification were 0.230 9-0.469 0 ng·mL-1.UPLC-MS/MS method can be used for rapid qualitative and quantitative screening of 3-nitropyrrole and thiourea.Conclusion:The method is simple,sensitive,convenient,accurate,and the analysis time is as short as 6 min.It can be used for the qualitative and quantitative identification of 3-nitropyrrole and thiourea in pioglitazone hydrochloride tablets.关键词
3-硝基吡咯/硫脲/吡格列酮片/UPLC-MS/MS/定性鉴别/定量检查Key words
3-nitropyrrole/Thiourea/Pioglitazone tablets/UPLC-MS/MS/Qualitative identification/Quantitative inspection分类
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吴月霞,朱艳春,陈杰..盐酸吡格列酮片中3-硝基吡咯和硫脲的定性定量方法研究[J].中国药物评价,2024,41(2):101-104,4.
