Quantification of 17-desacetyl norgestimate in human plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and its application to bioequivalence study
10.1016/j.jpha.2014.09.004
- Author:
Saxena Ashish
;
Gupta Kumar Arun
;
Kumar Praveen V.
;
Nainar Sundaramoorthi M.
;
Bob Manoj
;
Kasibhatta Ravisekhar
- Publication Type:Journal Article
- Keywords:
17-desacetyl norgesti-mate;
UPLC-MS/MS;
Human plasma
- From:
Journal of Pharmaceutical Analysis
2015;(2):93-100
- CountryChina
- Language:Chinese
-
Abstract:
A rapid and sensitive ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) method was developed and validated for the estimation of 17-desacetyl norgestimate in human plasma using solid-phase extraction technique. 17-desacetyl norgestimate D6 was used as the internal standard. Simple gradient chromatographic conditions and mass spectrometric detection enabled accurate and precise measurement of 17-desacetyl norgestimate at sub-picogram levels. The proposed method was validated for a linear range of 20–5000 pg/mL with a correlation coefficient Z 0.9988. The intra-run and inter-run precision and accuracy were within 10%. The overall recoveries for 17-desacetyl norgestimate and 17-desacetyl norgestimate D6 were 96.30%and 93.90%, respectively. The total run time was 4.5 min. The developed method was applied for the determination of the pharmacokinetic parameters of 17-desacetyl norgestimate following a single oral administration of a norgestimate and ethinyl estradiol 0.250 mg/0.035 mg tablets in 35 healthy female volunteers.
