| 1 | Quantification of 17-desacetyl norgestimate in human plasma by liquid chromatography–tandem mass spectrometry (LC–MS/MS) and its application to bioequivalence study显示文摘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/m L 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 estradiol0.250 mg/0.035 mg tablets in 35 healthy female volunteers. | Ashish Saxena Arun Kumar Gupta V.Praveen Kumar M.Sundaramoorthi Nainar Manoj Bob Ravisekhar Kasibhatta | 2015 | Journal of Pharmaceutical Analysis2015，5，2： | 0 |
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