Abstract:
:A stability-indicating liquid chromatographic method for the determination of degradation products and impurities in Vagifem, estradiol vaginal tablets has been developed and validated. Vagifem is a low dose preparation containing only 25microg 17beta-estradiol in a tablet matrix of 80mg (a drug to excipient ratio of 1:3200). This paper presents the rationale for the optimization of the sample preparation in order to minimize placebo interference as well as validation data for linearity, accuracy, precision, ruggedness, specificity and limits of detection and quantification. Data shows that the method is suitable for routine analysis of minute amounts of estradiol impurities.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Nygaard L,Drøhse Kilde H,Andersen SG,Henriksen L,Overby Vdoi
10.1016/S0731-7085(03)00501-6subject
Has Abstractpub_date
2004-02-04 00:00:00pages
265-76issue
2eissn
0731-7085issn
1873-264Xpii
S0731708503005016journal_volume
34pub_type
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