检索规则说明:AND代表“并且”;OR代表“或者”;NOT代表“不包含”;(注意必须大写,运算符两边需空一格)
检 索 范 例 :范例一: (K=图书馆学 OR K=情报学) AND A=范并思 范例二:J=计算机应用与软件 AND (U=C++ OR U=Basic) NOT M=Visual
作 者:庄波阳 楼永明 ZHUANG Bo-yang;LOU Yong-ming(Fujian Food and Drug Certification and Evaluation Center,Fuzhou 350001,China;Fujian Institute For Food and Drug Quality Control,Fuzhou 350001,China)
机构地区:[1]福建省食品药品认证审评中心,福建福州350001 [2]福建省食品药品质量检验研究院,福建福州350001
出 处:《海峡药学》2020年第11期84-86,共3页Strait Pharmaceutical Journal
摘 要:目的建立液相色谱-加校正因子的主成份自身对照法测定达泊西汀中杂质3-氯苯丙醇和甲奈酚的方法。方法色谱柱INTERSIL C 18(2.1 mm×150 mm,3μm);磷酸盐缓冲液(pH=7.5)为流动相A,乙腈为流动相B,进行梯度洗脱;流速为0.8 mL·min-1;检测波长为210 nm。结果3-氯苯丙醇和甲奈酚的校正因子分别为2.8、0.53。达泊西汀、3-氯苯丙醇和甲奈酚的质量浓度在(0.265~0.795)μg·mL-1、(0.260~0.780)μg·mL-1、(0.263~0.788)μg·mL-1范围内与峰面积呈良好的线性关系(r均不低于0.9995),3-氯苯丙醇和甲奈酚检出限分别为0.065μg·mL-1、0.016μg·mL-1,3-氯苯丙醇和甲奈酚平均回收率分别为97.2%(RSD=1.2%)、99.2%(RSD=0.6%)。结论本方法灵敏、准确,可作为达泊西汀中杂质3-氯苯丙醇和甲奈酚含量测定。OBJECTIVE To establish an HPLC-Principal Component Self-Control with Correct Factor method for determining the contents of 3-chlorophenyl alcohol and 1-naphthol in dapoxetine.METHODS INTERSIL C18(2.1 mm×150 mm,3μm),the mobile phase consisted of Potassium Phosphate Monobasic(pH=7.5)and acetonitrile at the flow rate of 0.8 mL·min-1(gradient elution),The detection wavelength and 210 nm.RESULTS The correction factors of 3-chlorophenyl alcohol and 1-naphthol were 2.8 and 0.53.The linear range of dapoxetine,3-chlorophenyl alcohol and 1-naphthol were(0.265-0.795)μg·mL-1,(0.260-0.780)μg·mL-1 and(0.263~0.788)μg·mL-1(r≥0.9995).The limits of detection were 0.065μg·mL-1,0.016μg·mL-1.The average recovery rates of 3-chlorophenyl alcohol and 1-naphthol were 97.2%(RSD=1.2%)and 99.2%(RSD=0.6%).CONCLUSION The method is sensitive,accurate and can be used to determine 3-chlorophenyl alcohol and 1-naphthol in dapoxetine.
关 键 词:加校正因子的主成份自身对照法 高效液相色谱法 达泊西汀 3-氯苯丙醇 甲奈酚
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在链接到云南高校图书馆文献保障联盟下载...
云南高校图书馆联盟文献共享服务平台 版权所有©
您的IP:216.73.216.116