Volume 5 Issue 2
Apr.  2015
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Ashish Saxena, Arun Kumar Gupta, V. Praveen Kumar, M. Sundaramoorthi Nainar, Manoj Bob, Ravisekhar Kasibhatta. Quantification of 17-desacetyl norgestimate in human plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and its application to bioequivalence study[J]. Journal of Pharmaceutical Analysis, 2015, (2): 93-100. doi: 10.1016/j.jpha.2014.09.004
Citation: Ashish Saxena, Arun Kumar Gupta, V. Praveen Kumar, M. Sundaramoorthi Nainar, Manoj Bob, Ravisekhar Kasibhatta. Quantification of 17-desacetyl norgestimate in human plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and its application to bioequivalence study[J]. Journal of Pharmaceutical Analysis, 2015, (2): 93-100. doi: 10.1016/j.jpha.2014.09.004

Quantification of 17-desacetyl norgestimate in human plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and its application to bioequivalence study

doi: 10.1016/j.jpha.2014.09.004
Funds:

Lupin Bioresearch Center (Maharashtra, India)

the grant of Doctorate in Philosophy in Pharmacy by Ashish Saxena, Research Scholar from Faculty of Pharmacy, Pacific University (Rajasthan, India)

  • Publish Date: Apr. 10, 2015
  • 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.
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