OBJECTIVE To develop a RP-HPLC method with pre-column derivatization for the determination of L-cysteine monohydrochloride in edaravone injection. METHODS 2,4-Dinitrochlorobenzene was used for the pre-column derivating agent. The RP-HPLC system consisted of an Agilent HC C18 column（4.6 mm×250 mm，5 μm）,mobile phase of acetonitrile-0.014 mol·L-1K2HPO4（50∶50）(adjusted to pH 8.2 with the phosphoric acid) at 1.0 mL·min-1. The detection wavelength was 360 nm. RESULTS The calibration curve was linear within the range of 0.012 9-0.077 6 μg for L-cysteine monohydrochloride (r=0.999 0). The average recovery was 99.0% and RSD was 1.9%（n=9）. CONCLUSION The method could be used for the determination of L-cysteine monohydrochloride in edaravone injection.
Key words
2 /
4-dinitrochlorobenzene /
pre-column derivatization /
L-cysteine- monohydrochloride /
edaravone injection
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References
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