关键词: font-size:medium, ">3-硝基吡咯；硫脲；吡格列酮片；UPLC-MS/MS；定性鉴别；定量检查

Abstract: Objective： Oestablish a UPLC-MS/MS method for qualitative and quantitative determination of 3-nitropyrrole and thiourea 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 solution. 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.

Key words: 3-nitropyrrole, Thiourea, Pioglitazone tablets, UPLC-MS/MS, Qualitative identification, Quantitative inspection