Modification of the U.S.P. dissolution method for the analysis of norethindrone and ethinyl estradiol tablets.
A modification of the U.S.P. dissolution method for the quantitation of norethindrone and ethinyl estradiol tablets is proposed. This modification consists of the use of distilled water as the dissolution medium instead of 0.1 N hydrochloric acid (HCl) and/or neutralization of 0.1 N HCl with sodium carbonate prior to analysis. Statistical analysis of the results indicate that there are no significant differences between the dissolution in 0.1 N HCl and the dissolution in distilled water (p < 0.05) for norethindrone and ethinyl estradiol.
Dorantes
A
A
University of Texas at Austin, College of Pharmacy, Pharmaceutics Division 78712-1074.
Stavchansky
S
S
D002851:Chromatography, High Pressure Liquid; D003277:Contraceptives, Oral, Combined / Q000032:analysis*; D004997:Ethinyl Estradiol / Q000032:analysis*; D007202:Indicators and Reagents; D009640:Norethindrone / Q000032:analysis*; D012995:Solubility; D013607:Tablets
D003277:Contraceptives, Oral, Combined; D007202:Indicators and Reagents; D013607:Tablets; D004997:Ethinyl Estradiol; D009640:Norethindrone