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 | Praveen Kumar V.,Lupin Bio Research Center | And 4 more authors.
International Journal of Pharmacy and Pharmaceutical Sciences | Year: 2014

Methods: The ultra-performance liquid chromatography–tandem mass spectrometry (UPLC-MS/MS) method with solid-phase extraction technique utilized Strata X 33μ polymeric reversed phase (30 mg/mL), extraction cartridge. Simple gradient chromatographic conditions and selective reaction monitoring in mass spectrometric detection enabled accurate and precise measurement of urapidil at nanogram levels in 0.1 mL of human plasma. The method used a deuterium labeled internal standard.Results: The method was validated for a linear range of 5–500 ng/mL for urapidil with a correlation coefficient ≥ 0.99 The intra-run and inter-run precision and accuracy were within 10%. The overall recoveries for urapidil and urapidil D4 were more than 90%. The urapidil was found to be stable in plasma matrix and aqueous media.Conclusion: The developed and validated method was specific, sensitive and reproducible in the analysis of clinical samples interspersed with quality control samples under freshly prepared calibration standards. The method was applied for the determination of the pharmacokinetic parameters of urapidil following a single oral administration of urapidil 60 mg capsules in nineteen healthy Indian male volunteers for fasting and fed study.Objective: A rapid and selective quantitative method was developed and validated in human plasma for urapidil pharmacokinetic study in healthy Indian volunteers. © 2014, International Journal of Pharmacy and Pharmaceutical Sciences. All right reserved.


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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