Determination of the Migration of Auxiliary Lubricants from Halogenated Butyl Rubber Stoppers to Carboxylic Acid Drugs
Using recovery rate and precision as evaluation indicators,the feasibility of methyl esterification gas chromatography,non-derivatization gas chromatography,and HPLC method with charged aerosol detector(CAD)for determining the migration of lubricants in carboxylic acid drugs was investigated.The results showed that compared with the methyl esterification gas chromatography and the non-derivatization gas chromatography,the HPLC-CAD method had higher recovery rate and precision.The recovery rate,precision,and detection limit of lubricant palmitic acid by the HPLC-CAD method were 103.5％-107.8％,1.6％,and 1.01 μg/mL,respectively.Then,the recovery rate,precision,and detection limit of lubricant stearic acid were 100.9％-109.3％,1.4％,and 1.00 μg/mL,respectively.The valproic acid injection after accelerated storage for 0 and 3 months was detected by HPLC-CAD method,and no migration of lubricant palmitic acid and stearic acid was found from halogenated butyl rubber stoppers to the solution.The HPLC-CAD method established in this paper can be used to detect the migration of lubricants from halogenated butyl rubber stoppers to carboxylic acid drugs.
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