Separation and Detection of Trimethylamine in Levocarnitine Injection by Ion Chromatography
LENG Yu-huan1,2, ZHAO Liang-dong2, CHEN Yan-ming2, ZHOU Ming-hua1, MA Jun-kai1*
1. Hubei Key Laboratory of Wudang Local Chinese Medicine Research, School of Pharmacy, Hubei University of Medicine, Shiyan 442000, China; 2. Beijing Haizhen Pharmaceutical Technology Co., Ltd., Beijing 101300, China
Abstract：OBJECTIVE To establish a method for the separation,extraction and detection of trimethylamine in levocarnitine injection. METHODS The L9(34) orthogonal design was carried out in order to optimize the extraction method of trimethylamine in levocarnitine injection, which was finally established as follows: 0.25 mol·L-1 NaOH solution was used to create an alkaline environment, heated at 40 ℃ for 20 min, N2 flow of 0.4 L·min-1 was connected, and the gas was absorbed by 0.1 mol·L-1 methanesulfonic acid solution. DionexIonpACTM CS12A(4.0 mm×250 mm) column and DionexIonpACTM CG12A(4.0 mm×50 mm) protective column were adopted, using 17 mmol·L-1 methanesulfonic acid solution as eluent at a flow rate of 0.5 mL·min-1, the column temperature was maintained at 30 ℃, and conductivity detection was performed. RESULTS Trimethylamine showed good linear relationship within the range of 0.30-48.64 μg·mL-1, the correlation coefficient was 0.999 3, the detection limit was 0.012 μg·mL-1(S/N=3), the quantification limit was 0.3 μg·mL-1 (S/N=10), the precision was good, and the solution was stable for 24 h at room temperature and 48 h at 2-8 ℃. The average recoveries were in the range of 97.33%-100.82%, and the RSD value was 1.07% (n=9). CONCLUSION The method can effectively extract and isolate trimethylamine in levocarnitine injection, and the ion chromatography detection method is proved to have high sensitivity, recovery and reproducibility.
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2022, Vol. 57 
