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Background <p>Prefilled syringes are commonly used in pharmaceutical products; however, volatile organic compounds leaching from plastic or elastomeric components can pose potential health risks. A sensitive and specific GC-FID method was developed and validated for the determination of volatile organic compounds in Sumatriptan Injection (6&#xa0;mg/0.5 mL).</p> Methodology <p>The method targets a mixture of volatile organic compounds with boiling points ranging from 40&#xa0;°C to 225&#xa0;°C. Separation was achieved using an HP-5-MS column, with a temperature program of 10&#xa0;°C/min for the first 10&#xa0;min and 25&#xa0;°C/min thereafter. Nitrogen was used as the carrier gas (25 mL/min), with hydrogen (30 mL/min) and zero air (300 mL/min) for flame generation.</p> Results <p> The method demonstrated high linearity (r<sup>2</sup>&gt; 0.99), with a limit of quantification of 0.060 ppm. The Limit of Quantification accuracy and precision ranged from 77.83% to 115.55% and ≤ 4.88% RSD, respectively. Accuracy at 50%, 100%, and 150% concentration levels ranged from 94.26–105.21%, 93.78–97.68%, and 89.56–94.49%, respectively, while precision (%RSD) at these levels ranged from 1.98–2.65%, 1.75–2.32%, and 0.16–0.50%, respectively.</p> Conclusions <p> The validated GC-FID method is accurate, precise and highly sensitive for detecting trace-level VOCs in parenteral formulations. With excellent linearity and reproducibility, it is well-suited for risk assessment and ensuring the quality and safety of injectable drug products such as Sumatriptan Injection.</p>

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Development and Validation of a GC-FID Method for Quantification of VOCs in Sumatriptan Injection

  • 期刊论文

  • 发表日期：

    2026年1月24日

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  • B Arun,
  • K. B. Premakumari,
  • D Prabakaran,
  • P Chitra

摘要

Background

Prefilled syringes are commonly used in pharmaceutical products; however, volatile organic compounds leaching from plastic or elastomeric components can pose potential health risks. A sensitive and specific GC-FID method was developed and validated for the determination of volatile organic compounds in Sumatriptan Injection (6 mg/0.5 mL).

Methodology

The method targets a mixture of volatile organic compounds with boiling points ranging from 40 °C to 225 °C. Separation was achieved using an HP-5-MS column, with a temperature program of 10 °C/min for the first 10 min and 25 °C/min thereafter. Nitrogen was used as the carrier gas (25 mL/min), with hydrogen (30 mL/min) and zero air (300 mL/min) for flame generation.

Results

The method demonstrated high linearity (r2> 0.99), with a limit of quantification of 0.060 ppm. The Limit of Quantification accuracy and precision ranged from 77.83% to 115.55% and ≤ 4.88% RSD, respectively. Accuracy at 50%, 100%, and 150% concentration levels ranged from 94.26–105.21%, 93.78–97.68%, and 89.56–94.49%, respectively, while precision (%RSD) at these levels ranged from 1.98–2.65%, 1.75–2.32%, and 0.16–0.50%, respectively.

Conclusions

The validated GC-FID method is accurate, precise and highly sensitive for detecting trace-level VOCs in parenteral formulations. With excellent linearity and reproducibility, it is well-suited for risk assessment and ensuring the quality and safety of injectable drug products such as Sumatriptan Injection.