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作 者:万青 王珺 刘铜梅 WAN Qing;WANG Jun;LIU Tongmei(Nanjing ChiaTai Tianqing Pharmaceutical Co.,Ltd.,Nanjing 210046,China)
机构地区:[1]南京正大天晴制药有限公司,江苏南京210046
出 处:《化工技术与开发》2023年第7期47-50,共4页Technology & Development of Chemical Industry
摘 要:采用CP-Sil 8 CB毛细管柱(30m×0.32mm×1.0μm,Agilent)作为色谱柱,氢火焰离子化检测器,柱温100℃,进样口温度200℃,检测器温度250℃,载气为氮气,流速为5m L·min-1,建立了气相色谱法测定盐酸法舒地尔中高哌嗪的方法。高哌嗪进样浓度为0.099~1.986mg·m L~(-1)时,线性关系良好,r≥0.9999;平均回收率为99.48%,RSD为0.63%(n=9)。溶液在8h内稳定,精密度和重复性的RSD均小于2.0%,耐用性良好。本方法的精密度和准确度高,可用于盐酸法舒地尔中高哌嗪的检测。A GC method for the determination of homopiperazine of Fasudil Hydrochloride was established.The related substances was detected by CP-Sil 8 CB capillary column with FID detector.The column temperature was 100℃,the inlet temperature was 200℃,FID detector temperature was 260℃,the carried gas flow rate was 5 mL/min.The homopiperazine had a good linear relationship within the range of 0.099~1.986 mg/mL(r=0.9999),the average recovery was 99.48%,RSD was 0.63%(n=9).The solution was stable within 8h,and the RSDs precision and repeatability were less than 2.0%.The method had strong specificity,good precision and high accuracy,and could be used for the detection of homopiperazine in fasudil hydrochloride.
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