OBJECTIVE To establish a HPLC
method for the d etermination of leuprorelin and
impurities in leuprorelin
acetate injection. METHODS Reversed-phase chromatographic separation was carried ou t on a Kromasil C 18-ODS column(150 mm×4.6 mm,5 μm)with an eluent mix ture constituted by A(800
ml H 2O+21 ml triethylamine, and the pH be adjusted t o 3.0 with phosphoric acid):B(n-propylalcohol:acetonitril=2∶3)=84∶16. The ultraviolet detec tion was at 220 nm. The quantitative determination of leuprorelin was performed with external
standard method and the impurity limitation of leuprorelin was pe rformed with contrast method.RESULT Complete separation was ac hieved among leuprorelin and other impurities under optimum conditions.No int erference from
injection accessories was found. The standard curve was linear w ithin the concentration
range of 9.198 to 82.78 μg·ml -1 for leuprore li n and the detection limit was 1.93 ng when S/N was 3.The recoveries of leupror elin were in the range of 98.74% to 100.3% with RSD less than 1.5%. CONCLUSION The proposed method is simple,accurate,reproducible and highly selective.
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