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Modification of the U.S.P. dissolution method for the analysis of norethindrone and ethinyl estradiol tablets

✍ Scribed by Angelica Dorantes; Salomon Stavchansky


Publisher
John Wiley and Sons
Year
1994
Tongue
English
Weight
344 KB
Volume
83
Category
Article
ISSN
0022-3549

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✦ Synopsis


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 (HCI) and/or neutralization of 0.1 N HCI 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 HCI and the dissolution in distilled water (p < 0.05) for norethindrone and ethinyl estradiol.

and distilled water (Table 1). The relative SDs are not >3 % ,


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## Abstract An ultra‐sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for the analysis of oral contraceptive ethinyl estradiol (EE) was developed and validated over the curve range of 2.5–500 pg/mL using 1 mL of human plasma sample. Ethinyl estradiol and the internal stand