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 25 μg 17β-estradiol in a tablet matrix of 80 mg (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.
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