Determination of norgestimate and its metabolites in human serum using high-performance liquid chromatography with tandem mass spectrometric detection |
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| Authors: | F. A. Wong R. W. Edom M. Duda J. P. Tischio M. Huang S. Juzwin G. Tegegne |
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| Affiliation: | a Drug Metabolism Department, R.W. Johnson Pharmaceutical Research Institute, Ortho McNeil Pharmaceutical Corporation, Raritan, NJ 08869, USA;b NACL, Belleville, NJ 07109, USA;c LabCorp, Clinical Trials-Analytical Chemistry, 69 First Avenue, Raritan, NJ 08869, USA;d Pharmaceutical Consulting Services, Manasquan, NJ 08736, USA;e Drug Metabolism, Bristol Myers Squibb, New Brunswick, NJ 08902, USA |
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| Abstract: | A rapid and reliable analytical method is described for the simultaneous determination of a synthetic progestin norgestimate (NGM), and its metabolites, 17-deacetylnorgestimate (17-DA-NGM), 3-ketonorgestimate (3-keto-NGM) and norgestrel (NGL) in human serum using reversed phase high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS-MS) detection. The assay was linear over the concentration ranges of 0.1–5.0 ng/ml for 17-DA-NGM and NGL and 0.5–5.0 ng/ml for NGM and 3-keto-NGM. The inter-assay reproducibility was consistently less than 10%. The overall recovery of the analytes ranged from 72 to 92%. Serum profiles following oral administration of norgestimate to female volunteers are presented. |
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| Keywords: | Norgestimate 17-Deacetylnorgestimate 3-Ketonorgestimate Norgestrel |
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