Safety Monitoring

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

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  • 1. 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;
    2. State Key Laboratory of Long-acting and Targeting Drug Delivery System, Luye Pharma Group Ltd., Yantai 264003, China

Revised date: 2022-12-03

  Online published: 2024-06-24

Abstract

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 mL·min-1. The column temperature was 25 ℃ and the sampling volume was 20 μL. The ELSD was maintained 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=0.999 4). Tween 20 showed good linearity within the range of 0.12-0.3 mg·mL-1(r=0.999 6). 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.

Cite this article

MA Yong-chao, JI Wei, XUE Ying, XIA Yun-qing, ZHOU Feng-mei, LIU Wan-hui, XU Li-xiao . Simultaneous determination of polysorbate 20 and polyethylene glycol 4000 in paliperidone palmitate injection by HPLC-ELSD*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(3) : 480 -485 . DOI: 10.16155/j.0254-1793.2023.03.15

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