ESTIMATION OF ETONOGESTREL IN HUMAN PLASMA BY USING LC–ESI–MS/MS METHOD
DOI:
https://doi.org/10.22159/ijpps.2017v9i12.20946Keywords:
Etonogestrel, Liquid-Liquid Extraction, Human plasma, PharmacokineticsAbstract
Objective: The aspiration of the present study was to develop simple, robust and reliable liquid chromatography/electro spray ionization tandem mass spectrometry (LC-MS/MS) (Agilent Technologies) assay method for the quantification of etonogestrel in human serum by using etonogestrel d6 as internal standard (IS).
Methods: An easy Liquid-Liquid Extraction (LLE) sample processing method was used to extract etonogestrel from plasma and chromatographic method was developed with run time 3.5min with linear calibration curve ranges from 50-3604 pg/mL for both etonogestrel and etonogestrel d6 and chromatographic method validated by determining carryover test, sensitivity, matrix effect, linearity, precision, accuracy, recovery, dilution integrity and stability. The developed method was used for pharmacokinetic study of 75mcg desogestrel tablet formulation under fasting condition in healthy females.
Results: The validation showed the developed method was accurate with the results of validated parameters were met acceptance criteria as per Food and Drug Administration (FDA) guidelines. The validated method successfully was used for pharmacokinetic study of 75mcg desogestrel tablet in healthy females and quantified the amount of etonogestrel and IS.
Conclusion: The developed method for etonogestrel in human plasma has been validated and used in pharmacokinetic studies.Â
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