An isocratic technique was developed for the analysis of leuprolide acetate
by high performance liquid chromatography (HPLC) using 220 nm UV detection
, C18MICROSORB-MV(TM) column (4.6 mm x 15 cm), mobile phase (0.03 M, 77% di
basic ammonium phosphate buffer: 23% acetonitrile), and 2.0 mL/min flow rat
e.
The coefficient of variation (C.V.) for precision and proportionality assay
s was lower than 2% for all concentrations studied. The detection limit and
tailing factor for leuprolide acetate were 100 ng/mL (signal-to-noise rati
o of 3:1) and 1.16-1.26, respectively.