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| Determination of the residual amount of trichloromethane in viaminate by gas chromatography |
| Li Yuxin1,2, Lan Wen1,2, Liu Yanming1,2 |
| 1. Hunan Institute for Drug Control and Texting, Changsha 410001, China； 2. NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research， Changsha 410001, China |
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Abstract To develop a method for determinating the residual amounts of trichloromethane in Viaminate raw material by gas chromatography, which can be used for qualitative and quantitative analysis of trichloromethane. Gas Chromatography was performed with electron capture detector (ECD). The separation of trichloromethane was performed by an DB-1701 capillary column using temperature programming method. Trichloromethane can be effectively separated from adjacent peaks and have a good linear relationship in their concentration ranges of 0.633 79 μg·mL-1 to 31.689 90 μg·mL-1 (r＞0.999); The average recovery rate (n=6) is 101.81%~102.49%. The method was used to detect residual solvent in 16 batches of samples from all enterprises that obtained the approval number of viaminate. The residual amount of trichloromethane in 16 batches of samples did not exceed the limit specified in item 0861 of the fourth General rule of the 2020 edition of Chinese Pharmacopoeia. The method is simple, reproducible and accurate can be used for the determination of Trichloromethane in Viaminate.
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