Novel reversed-phase HPLC method for simultaneous determination of ethynodiol diacetate (EDA)/ethinyl estradiol (EE) in pharmaceutical dosage form.
Agilent ZORBAX SB-phenyl
HPLC method
drug product
ethinyl estradiol (EE)
ethynodiol diacetate (EDA)
method validation
Journal
Biomedical chromatography : BMC
ISSN: 1099-0801
Titre abrégé: Biomed Chromatogr
Pays: England
ID NLM: 8610241
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
revised:
06
12
2020
received:
11
11
2020
accepted:
15
12
2020
pubmed:
29
12
2020
medline:
10
7
2021
entrez:
28
12
2020
Statut:
ppublish
Résumé
Ethynodiol diacetate (EDA) and ethinyl estradiol (EE) tablets are indicated to prevent pregnancy in women who use oral contraceptives as a contraception method. EDA and EE were separated by reversed-phase HPLC using Agilent ZORBAX SB-Phenyl column, 4.6 mm × 15 cm, 5 μm, using a gradient mixture of acetonitrile and Milli-Q water as mobile phase. The linearity and recovery were found in the range of 0.025-0.25 mg/mL and 0.05-0.18 mg/mL for EDA and 0.001-0.01 mg/mL and 0.002-0.007 mg/mL for EE, respectively. The method is validated according to the regulatory guidelines concerning system suitability, specificity, repeatability, recovery, linearity, robustness, and stability of the sample solution.
Substances chimiques
Contraceptives, Oral
0
Tablets
0
Ethynodiol Diacetate
62H10A1236
ethynodiol
9E01C36A9S
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e5055Informations de copyright
© 2020 John Wiley & Sons, Ltd.
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