12/17/2017
New LC-MS/MS bioanalytical method for quantification of Estradiol and Estrone
A new method has been successfully developed and validated for determination of Unconjugated Estradiol and Estrone in human plasma by LC-MS/MS with LLOQ of 2 pg/mL and 5 pg/mL respectively.
The method involves a liquid-liquid extraction procedure and a subsequent derivatization procedure. Estradiol, Estrone and internal standards are measured by reversed phase ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS).
The possible metabolite back conversion has been evaluated during method validation.
This method has been successfully used to analyze samples from different clinical studies and the incurred sample reproducibility has met all acceptance crieria.
The development of this assay adds to the list of high sensitivity methods at Anapharm together with Tiotropium, Fluticasone, Salmeterol, Formoterol or Ethinyl Estradiol.
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A 5 Plex method for the detection of metabolic biomarkers in human plasma was developed using the U-PLEX technology on the MSD platform.
The complexities surrounding this method were the establishment of endogenous QCs for each chosen biomarker and evaluating the potential use and need for buffer QCs vs matrix QCs where applicable. Additional challenges were faced while trying to ascertain a single minimum required dilution to enable accurate quantification of all biomarkers simultaneously, encompassing the different detection ranges and limits for each biomarker.
READ MOREConsiderations to properly assess drug stability within biological samples
Assessing drug stability during method development and validation is of paramount importance. The concentration of the target analyte must remain unaffected throughout the lifecycle of the samples to ensure the reliability of the assay data. However, a decrease in analyte concentration in a biological fluid is not always due to a lack of stability.
READ MOREChallenges in development of robust analytical methods for the quantitation of low molecular weight compounds by LC-MS/MS
Method development can be considered one of the most challenging task in a Bioanalytical laboratory. When working with LC-MS/MS and low molecular weight drugs, low degree of ionization, poor fragmentation, higher presence of isobaric compounds or analyte loss due to their high volatility can get in the way of a successful method development.
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