DRUG STANDARDSSeparation of Quingestanol (cas 10592-65-1) Acetate from Sesame Oil Solution and Its Determination in Combinations withEthinyl Estradiol or Quinestrol

Add time:08/15/2019    Source:sciencedirect.com

Quingestanol (cas 10592-65-1) acetate, norethindrone acetate 3-cyclopentyl enol ether, was not separable from its sesame oil dosage form vehicle as the intact compound using chromatography procedures that depend on differences in polarity. The steroid can be retained quantitatively on a Florisil column treated with a relatively high concentration of ammoniacal silver nitrate and then quantitatively eluted with ethanolic ammonium chloride. The progestin can be determined selectively in the presence of its products of solvolytic or oxidative degradation by UV spectrophotometry after treatment with sodium borohydride; the chromophore of the decomposition products is eliminated by this process while that of the intact compound is unaffected. Quinestrol or ethinyl estradiol, which may be coformulated with the progestin, does not interfere with its determination. Methods for the quantitative determination of the declared steroids in quingestanol acetate formulations and for the estimation of degradation products of the progestin are presented.

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