CHINESE JOURNAL OF DRUG EVALUATION ›› 2022, Vol. 39 ›› Issue (5): 391-394.

Previous Articles     Next Articles

The Research on a GC-MS Method for Simultaneous Determination of Phthalate Plasticizers in Ligustrazine Phosphate and Sodium Chloride Injection

  

  1. Inspection, Examination and Certification Centre, Liaoning Institute for Drug Control/NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drug, Liaoning Shenyang 110036, China
  • Received:2022-06-10 Revised:2022-08-04 Online:2022-10-28 Published:2022-10-28

Abstract: Objective:A GC-MS method was established for the determination of 21phthalate plasticizers in Ligustrazine Phosphate and Sodium Chloride Injection. Methods:The determin ation was performed on DB-5MS column at the flow rate of 1.0 mL·min-1 using helium as carrier gas, injector temperature was 260 ℃ by temperature programming. Electron impact(EI)ionization mode was used, MRM was used for quantity analysis, the assays of phthalates elasticizers in 3 batches Ligustrazine Phosphate and Sodium Chloride Injection were determined. Results: 21 kinds of phthalates could be completely separated under the condition of GC-MS. The linear ranges were 80~2 000 ng·mL-1. The limit of detection was more than 2 ng·mL-1 and average recoveries were 90.7%~97.1%. Conclusion:This work provided an effective, accurate, sensitive and simple method for the rapid detection of huge quantity of samples.

Key words: font-size:medium, ">GC-MS;Phthalate plasticizers;Ligustrazine Phosphate and Sodium Chloride Injection

CLC Number: 

[an error occurred while processing this directive]