Determination of norgestimate and its metabolites in human serum using high-performance liquid chromatography with tandem mass spectrometric detection.
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.
Wong
F A
FA
Drug Metabolism Department, R.W. Johnson Pharmaceutical Research Institute, Ortho McNeil Pharmaceutical Corporation, Raritan, NJ 08869, USA.
Edom
R W
RW
Duda
M
M
Tischio
J P
JP
Huang
M
M
Juzwin
S
S
Tegegne
G
G
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003280:Contraceptives, Oral, Synthetic / Q000097:blood*; D004338:Drug Combinations; D004355:Drug Stability; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000031:analogs & derivatives / Q000097:blood; D013058:Mass Spectrometry / Q000379:methods*; D015394:Molecular Structure; D009644:Norgestrel / Q000031:analogs & derivatives* / Q000097:blood; D010091:Oximes; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D003280:Contraceptives, Oral, Synthetic; D004338:Drug Combinations; D010091:Oximes; C025692:norgestrel acetate; D009644:Norgestrel; D016912:Levonorgestrel; C017576:norgestimate; C449219:norelgestromin