Lupin Bio Research Center

Pune, India

Lupin Bio Research Center

Pune, India

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Saxena A.,Lupin Bio Research Center | Saxena A.,Pacific University at Udaipur | Gupta A.K.,Pacific University at Udaipur | Kumar V.P.,Lupin Bio Research Center | And 4 more authors.
Journal of Pharmaceutical Analysis | Year: 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 ≥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. © 2014 Xi'an Jiaotong University.


Saxena A.,Lupin Bio Research Center | Saxena A.,Pacific University at Udaipur | Gupta A.,Pacific University at Udaipur | Kasibhatta R.,Lupin Bio Research Center | And 3 more authors.
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2014

A rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the estimation of gestodene in human plasma. Gestodene was extracted from human plasma by using solid-phase extraction technique. Gestodene D6 was used as the internal standard. An Acquity HSS-T3 column provided chromatographic separation of analytes followed by detection with mass spectrometry. The mass transition ion-pair was followed as m/z 326.2. →. 124.1 for gestodene and m/z 332.3. →. 129.1 for gestodene D6. The method involves a solid phase extraction from plasma, rapid derivatization with hydroxylamine to form oxime, simple gradient chromatographic conditions and mass spectrometric detection that enables detection at sub-picogram levels. The proposed method has been validated for a linear range of 50-11957. pg/ml with a correlation coefficient. ≥. 0.9994. The intra-run and inter-run precision and accuracy were within 10%. The overall recoveries for gestodene and gestodene D6 were 62.02% and 67.57% respectively. The total run time was 4.0. min. The developed method was applied for the determination of the pharmacokinetic parameters of gestodene following a single oral administration of a 2. ×. 0.06. mg gestodene tablets in 10 healthy female volunteers. © 2013 Elsevier B.V.


PubMed | Pacific University at Udaipur and Lupin Bio Research Center
Type: | Journal: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences | Year: 2014

A rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the estimation of gestodene in human plasma. Gestodene was extracted from human plasma by using solid-phase extraction technique. Gestodene D6 was used as the internal standard. An Acquity HSS-T3 column provided chromatographic separation of analytes followed by detection with mass spectrometry. The mass transition ion-pair was followed as m/z 326.2124.1 for gestodene and m/z 332.3129.1 for gestodene D6. The method involves a solid phase extraction from plasma, rapid derivatization with hydroxylamine to form oxime, simple gradient chromatographic conditions and mass spectrometric detection that enables detection at sub-picogram levels. The proposed method has been validated for a linear range of 50-11957pg/ml with a correlation coefficient0.9994. The intra-run and inter-run precision and accuracy were within 10%. The overall recoveries for gestodene and gestodene D6 were 62.02% and 67.57% respectively. The total run time was 4.0min. The developed method was applied for the determination of the pharmacokinetic parameters of gestodene following a single oral administration of a 20.06mg gestodene tablets in 10 healthy female volunteers.

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