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  

Determination of 3-Chlorophenyl Alcohol and 1-Naphthol in Dapoxetine by Principal Component Self-Control with Correct Factor

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 

分 类 号：R927[医药卫生—药学]