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2000
Volume 20, Issue 8
  • ISSN: 1573-4129
  • E-ISSN: 1875-676X

Abstract

Objective

The aim of the study was to establish a GC-MS method for the determination of extractable substances in the stoppers of Ceftriaxone sodium bottles for injection, to establish an HPLC method for the determination of vulcanizing agent and antioxidant in Ceftriaxone sodium for injection bottle stopper and to analyze the correlation between the volatile substances of the rubber stopper and the clarity of solution.

Methods

GC-MS method was used with capillary column Restek rtx-5 (30.0 m×0.25 mm, 0.25 µm), the carrier gas was He at the flow rate of 1.8mL·min-1, the column temperature was programmed temperature, and the scanning range was from29 to 600(/), and the volatile substances were using full scan. An inertsil ODS-3 column(250 mm×4.6 mm, 5 µm) was used for the HPLC analysis. The mobile phase A consisted of water containing 0.04% trifluoroacetic, and the mobile phase B consisted of acetonitrile containing 0.04% trifluoroacetic acid, the gradient elution was used, and the flow rate was set as 1.0 mL·min-1.

Results

Antioxidant BHT(264), silicone oil, and other organic compounds in the rubber stopper permeated and migrated to the sample with acceleration time by GC-MS. A good linearity was observed over the range of 0.5-100 μg·mL-1(>0.999). The detection limits of the vulcanizing agent and antioxidant were about 0.03 μg·mL-1, and the quantitation limits were about 0.1 μg·mL-1. The average recoveries (low, medium, and high) of antioxidants (168, 264, 330, 1076, 1010) and vulcanizing agents (carbon disulfide, sulfur) were between 90.0% and 110.0%, and the corresponding RSD were less than 5% (=9) by adding standard recovery experiments. The stability test showed that the antioxidant and the vulcanizing agent solution had good stability and was stable within 24 hours.

Conclusion

The GC-MS/HPLC method can be used to control the quality of the rubber stopper of cefuroxime sodium for injection. The compatibility study and comprehensive evaluation system of Ceftriaxone sodium for injection packaging materials have been initially formed.

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2024-09-16
2025-09-28

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/content/journals/cpa/10.2174/0115734129286160240909063156
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Research on Compatibility of Packaging Materials of High-Risk Cephalosporin Powder Injection and Establishment of Indicator Component Evaluation Method
Current Pharmaceutical Analysis 20, 743 (2024); https://doi.org/10.2174/0115734129286160240909063156
/content/journals/cpa/10.2174/0115734129286160240909063156
/content/journals/cpa/10.2174/0115734129286160240909063156
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  • Article Type:     Research Article
Keyword(s): antioxidant; carbon disulfide; cefuroxime sodium for injection; Gas chromatography-mass spectrometry; high-performance liquid chromatography; rubber stopper; vulcanizing agent

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