HPLC-ELSD法同时测定棕榈酸帕利哌酮注射剂中聚山梨酯20和聚乙二醇4000的含量  

Simultaneous determination of polysorbate 20 and polyethylene glycol 4000 in paliperidone palmitate injection by HPLC-ELSD

作　　者：马永超 姬巍 薛英 夏昀卿 周凤梅 刘万卉[1,2] 许丽晓 MA Yong-chao;JI Wei;XUE Ying;XIA Yun-qing;ZHOU Feng-mei;LIU Wan-hui;XU Li-xiao(School of Pharmacy,Key Laboratory of Molecular Pharmacology and Drug Evaluation(Yantai University),Ministry of Education,Collaborative Innovatio Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong,Yantai University,Yantai 264005,China;State Key Laboratory of Long-acting and Targeting Drug Delivery System,Luye Pharma Group Ltd.,Yantai 264003,China)

机构地区：[1]烟台大学新型制剂与生物技术药物研究山东省高校协同创新中心,分子药理和药物评价教育部重点实验室(烟台大学),烟台264005 [2]绿叶制药集团有限公司长效和靶向制剂国家重点实验室,烟台264003

出　　处：《药物分析杂志》2023年第3期480-485,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：山东省高等学校科技计划(基金立项编号J18KA275)。

摘　　要：目的:建立HPLC-ELSD法同时测定棕榈酸帕利哌酮注射液中聚山梨酯(polysorbate, Tween)20和聚乙二醇(polyethylene glycol, PEG)4000的含量。方法:采用TSK gel 3000 PWxl (7.8 mm×300 mm)色谱柱,以20 mmol·L^(-1)的乙酸铵水溶液-乙腈(60∶40)为流动相,流速为0.6 mL·min^(-1),柱温25℃,进样量20μL;采用蒸发光散射检测器(ELSD),雾化器温度与漂移管温度均为50℃,气体流速2.0 L·min^(-1)(0℃,1atm)。结果:PEG4000在0.3~0.75 mg·mL^(-1)范围内线性关系良好,r=0.999 4;Tween 20在0.12~0.3 mg·mL^(-1)范围内线性关系良好,r=0.999 6;PEG4000的检测限为0.02 mg·mL^(-1),定量限为0.03 mg·mL^(-1);Tween 20的检测限为0.05 mg·mL^(-1),定量限为0.07 mg·mL^(-1);PEG4000与Tween 20重复性的RSD分别为2.3%和1.9%;PEG4000的平均回收率为98.7%,RSD为0.90%(n=6);Tween 20的平均回收率为96.3%,RSD(n=6)为0.80%;结论:该方法、准确、可靠,可用于棕榈酸帕利哌酮注射液中Tween 20和PEG4000含量同时测定。Objective:To establish an HPLC-ELSD method for the simultaneous determination of Polysorbate(Tween)20 and Polyethylene Glycol(PEG)4000 in Paliperidone palmitate injection.Methods:The separation was performed on a TSK gel 3000 PWxl(7.8 mm×300 mm)column with 20 mmol·L^(-1) ammonium acetate aqueous solution and acetonitrile(60∶40)as the mobile phase by isocratic elution.And the flow rate was 0.6 m L·min^(-1).The column temperature was 25℃and the sampling volume was 20μL.The ELSD was main-tained at 50℃throughout the determination.The nebulizer gas flow rate was 2.0 L·min^(-1)(0℃,1 atm).Results:PEG4000 showed good linearity within the range of 0.3-0.75 mg·mL^(-1)(r=0.9994).Tween 20 showed good linearity within the range of 0.12-0.3 mg·mL^(-1)(r=0.9996).The minimum detection limit of PEG4000 and Tween 20 were 0.02 mg·mL^(-1),0.05 mg·mL^(-1),respectively.The minimum quantitative limit of PEG4000 and Tween 20 were 0.03 mg·mL^(-1),0.07 mg·mL^(-1),respectively.The repeatability RSD of PEG4000 and Tween 20 were 2.3%and 1.9%,respectively.The average recoveries of PEG4000 was 98.7%and the RSD was 0.90%(n=6).The average recovery of Tween 20 was 96.3%and the RSD was 0.80%(n=6).Conclusion:The method for simultaneous determination of Tween 20 and PEG4000 in Paliperidone palmitate injection by using HPLC-ELSD is precise and suitable.

关 键 词：棕榈酸帕利哌酮注射液 聚山梨酯20 聚乙二醇4000 高效液相色谱法 蒸发光散射检测 同时测定 

分 类 号：R917[医药卫生—药物分析学]