Detection of Epichlorohydrin Residue in Sevelamer Carbonate by GC-MS

OBJECTIVE To establish a gas chromatography-mass spectrometry method for the detection of epichlorohydrin in sevelamer carbonate, so as to meet the limit requirements in the quality standard of raw materials. METHODS This method utilized a DB-17MS column(30 m×0.25 mm, 0.25 μm), helium as carrier gas. The inlet temperature was 200℃. Ion source temperatrue was 230℃. MS quadrupole temperature was 150℃. Temperature program was used. The carrier flow was 1.0 mL·min^-1 and split ratio was 10:1. The quantitative ion was m/z 57. RESULTS Epichlorohydrin presented a good linear relationship within the range of 0.087-0.260 μg·mL^-1. The limit of quantitation was 0.045 μg·mL^-1 and the limit of detection was 0.017 μg·mL^-1. The average recovery was 98.4%. CONCLUSION This method is simple and fast, with strong specificity, good accuracy and high sensitivity. It can meet the requirement of limits value of the standard of sevelamer carbonate drug substance.