Quantitative estimation of ethanol content in eribulin mesylate injection using headspace gas chromatographic with flame ionization detector [HS-GC-FID]

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Published

15-06-2024

DOI:

https://doi.org/10.58414/SCIENTIFICTEMPER.2024.15.2.11

Keywords:

Ethanol content, HS-GC, Eribulin mesylate injection, ICH guidelines, Validation.

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Issue

Vol. 15 No. 02 (2024): The Scientific Temper

Section

SECTION B: PHYSICAL SCIENCES, PHARMACY, MATHS AND STATS

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Copyright (c) 2024 The Scientific Temper

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This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Authors

  • P. N. Malleswari Department of Chemistry, University College of Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India
  • P. V. S. Gupta Department of Chemistry, University College of Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India
  • S. V. M. Vardhan Department of Biochemistry, Krishna University, Dr. MRAR College of Post Graduation Studies, Nuzvid, Andhra Pradesh, India
  • D. Ramachandran Department of Chemistry, University College of Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India

Abstract

A specific HS-GC method has been developed, optimized, and validated for the quantitative estimation of ethanol content in eribulin mesylate injection. Chromatographic separation was achieved on DB-624 column (30 m x 0.32 mm, 1.8 μm), consisting of 6% cyanopropyl and 94% polydimethylsiloxane as stationary phase and passing nitrogen carrier gas. The performance of the method was assessed by evaluating the specificity, linearity, precision, and accuracy of experiments. The correlation coefficient value of the linearity experiment was 0.9999. The average recoveries for the accuracy were in the range of 98.7 to 102.4%. The results proved that the method is suitable for the quantitative estimation of ethanol content in eribulin mesylate injection.

How to Cite

Malleswari, P. N., Gupta, P. V. S., Vardhan, S. V. M., & Ramachandran, D. (2024). Quantitative estimation of ethanol content in eribulin mesylate injection using headspace gas chromatographic with flame ionization detector [HS-GC-FID]. The Scientific Temper, 15(02), 2039–2044. https://doi.org/10.58414/SCIENTIFICTEMPER.2024.15.2.11

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