HPLC Settings for Separating Certain Impurities in Norethindrone, Norgestrel, and Ethinyl Estradiol

Analytical Test

Organic Impurities

Analytical Technique

HPLC

Experimental Setting Value
Instrument Hewlett-Packard 1090 HPLC
Detector HP-1040 DAD, 4 nm bandwidth for chromatograms and 2 nm for spectra
Column 250 x 4 mm packed with LiChrosorb RP-18, 10 μm
Eluent 7:3 methanol:water
Flow Rate 1 ml/min
Concentration of Sample Solution 0.1% in eluent
Injection Volume 20 μL

References

  1. Gorog SH, B. Analysis of Steroids. 38. The use of high-performance liquid chromatography with diode-array UV detection for estimating impurity profiles of steroid drugs. Journal of Chromatography. 1987; 400:177-86.
  2. (View all citations for this reference)