Quantitative estimation of ethanol content in eribulin mesylate injection using headspace gas chromatographic with flame ionization detector [HS-GC-FID]
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https://doi.org/10.58414/SCIENTIFICTEMPER.2024.15.2.11Keywords:
Ethanol content, HS-GC, Eribulin mesylate injection, ICH guidelines, Validation.Dimensions Badge
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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.Abstract
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