Determination of Triethylamine and N,N-dimethylacetamide Residues in Pemetrexed Disodium by GC
Objective:To establish a method for the determination of triethylamine and N,N-dimethylacetamide in pemetrexed disodium(API).Method:Triethylamine is detected by DB-1 column,N,N-dimethylacetamide is detected by DB-WAX column,the detector temperature is 250℃,program temperature.Results:Triethylamine and N,N-dimethylacetamide had good linearities within their respective concentration ranges(R2＞0.995),with average recoveries of 99.38%and 96.40%.Conclusion:The method is accurate,reliable,and sensitive,suitable for the determination of triethylamine and N,N-dimethylacetamide in the drug substance of Pemetrexed Disodium.
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