Estradiol related substances by UPLC

<p> I am looking for UPLC methods for ethinyl estradiol and its related impurities from tablet formulations. Challenges are : the level of impurities are not more than 0.5% of a potent API (present at 0.03 mg/tablet) and the API and rel subs are poor UV chromophores.</p><p>Suggestions welcome.</p>

Answers

  • Hello Partha,

    I noticed your question posted on the Waters Community message board.  I also recognized your looking for methods for Estradiol and its related impurities?  This caught my eye as we have successfully been able to create a method and identify various impurity levels of Estradiol while using our newest technology called the ACQUITY UPSFC System.  This normal phase technique, while utilizing carbon dioxide as the main mobile phase, provides us the advantage of SFC (Supercritical Fluid Chromatography) separations, while taking advantage of all the benefits.  Please take a moment to review our Technical Brief.

  • Hello Partha,

    We also have recently published an application note demonstrating the use of UPLC with Xevo TQ-S for the analysis of estradiol, perhaps this might be useful as a reference.

    Karen

    Quantification of Estradiol at 2 pg/mL Using UPLC and Xevo TQ-S

    http://www.waters.com/waters/library.htm?cid=134613325&lid=134640081


    Quantification of Ethinyl Estradiol in Plasma at 1 pg/mL Using UPLC and evo TQ-S

    http://www.waters.com/waters/library.htm?cid=134613325&lid=134640120

  • I've run this by fluorescence which is way more sensitive than UV.  Set fluorometer to following settings Ex=280 Em=310  My low standard was 5 ng/mL which was a healthy peak.  Was running estradiol and ethynylestradiol.
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