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Development of a sensitive and rapid method for quantitation of (S)-(-)- and (R)-(+)-metoprolol in human plasma by chiral LC–ESI–MS/MS

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Journal of pharmaceutical Analysis 2014年第1期4卷 63-79页

作者： primal Sharma pritesh Contractor Swati Guttikar daxesh p.patel pranav S.Shrivastav Department of Chemistry School of Sciences Gujarat University Bioanalytical Research Department Veeda Clinical Research

A selective, sensitive and high throughput liquid chromatography-tandem mass spectro-metry （LC-ESI-MS/MS） method has been developed for separation and quantification of metoprolol enantiomers on a chiral Lux Amylose-2 （250 mm＆#215;4.6 mm, 5 mm） column. Solid phase extraction of （S）-（-）- and （R）-（t）-metoprolol and rac-metoprolol-d6 as an internal standard （IS） was achieved on Lichrosep DVB HL cartridges employing 200 mL human plasma. Both the analytes were chromatographically separated with a resolution factor of 2.24 using 15 mM ammonium acetate in water, pH 5.0 and 0.1% （v/v） diethyl amine in acetonitrile （50：50, v/v） as the mobile phase within 7.0 min. The precursor-product ion transitions for the enantiomers and IS were monitored in the multiple reaction monitoring and positive ionization mode. The method was validated over the concentration range of 0.500-500 ng/mL for both the enantiomers. Matrix effect was assessed by post-column analyte infusion experiment and the mean extraction recovery was greater than 94.0% for both the enantiomers at all quality control levels. The stability of analytes was evaluated in plasma and whole blood under different storage conditions. The method was successfully applied to a clinical study in 14 healthy volunteers after oral administration of 200 mg metoprolol tablet under fasting conditions. The assay reproducibility is shown by reanalysis of 68 incurred samples. The suitability of the developed method was assessed in comparison with＆amp;nbsp;different chromatographic methods developed for stereoselective analysis of metoprolol in biological matrices.

关键词： S-(-)-metoprolol R-(+)-metoprolol Chiral column Chromatographicseparation LC-ESI-MS/MS Human plasma

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Determination of lercanidipine in human plasma by an improved UpLC–MS/MS method for a bioequivalence study

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Journal of pharmaceutical Analysis 2016年第2期6卷 87-94页

作者： Darshan V.Chaudhary daxesh p.patel priyanka A.Shah Jaivik V.Shah Mallika Sanyal pranav S.Shrivastav Department of Chemistry School of Sciences Gujarat University Navrangpura Ahmedabad Gujarat 380009 India Laboratory of Metabolism Center for Cancer Research National Cancer Institute National Institutes of Health Building 37 Room 3106 Bethesda MD 20892 USA Department of Chemistry St. Xavier's College Navrangpura Ahmedabad Gujarat 380009 India

An improved and reliable ultra-performance liquid chromatography/tandem mass spectrometry （UpLC- MS/MS） method has been developed and validated for the determination of lercanidipine in human plasma. plasma samples with lercanidipine-d3 as an internal standard （IS） were prepared by solid phase extraction on phenomenex Strata-X cartridges using 100 μL of human plasma. Chromatographic analysis was performed on UpLC BEH C18 （50 mm × 2.1 mm, 1.7 μm） column under isocratic conditions. Linear calibration curves were obtained over a wide dynamic concentration range of 0.010-20.0 ng/mL. Matrix effect was assessed by post-column infusion, post-extraction spiking and standard-line slope methods. The mean extraction recovery was 〉 94% for the analyte and IS. Inter-batch and intra-hatch precision （% CV） across five quality controls was 〈 5.8%. Bioequivalence study was performed with 36 healthy sub- jects after oral administration of 10 mg of lercanidipine and the assay reproducibility was evaluated by reanalysis of 133 incurred samples.

关键词： Lercanidipine UpLC-MS/MS Bioequivalence Solid phase extraction Human plasma

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Determination of cilostazol and its active metabolite 3,4-dehydro cilostazol from small plasma volume by UpLC-MS/MS

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Journal of pharmaceutical Analysis 2015年第1期5卷 1-11页

作者： Nejal M.Bhatt Vijay D.Chavada daxesh p.patel primal Sharma Mallika Sanyal pranav S.Shrivastav Department of Chemistry School of SciencesGujarat UniversityNavrangpuraAhmedabad 380009GujaratIndia Department of Chemistry St.Xavier's CollegeNavrangpuraAhmedabad 380009GujaratIndia

A simple,rapid and sensitive ultra performance liquid chromatography-tandem mass spectrometry（UpLC-MS/MS） method has been developed for the simultaneous determination of cilostazol and its pharmacologically active metabolite 3,4-dehydro cilostazol in human plasma using deuterated analogs as internal standards（ISs）.plasma samples were prepared using solid phase extraction and chromatographic separation was performed on UpLC BEH C18（50 mm × 2.1 mm.1.7 μm） *** method was established over a concentration range of 0.5-1000 ng/mL for cilostazol and 0.5-500 ng/mL for 3.4-dehydro ***- and inter-batch precision（%CV） and accuracy for the analytes were found within 0.93-1.88 and 98.8-101.7% for cilostazol and 0.91-2.79 and 98.0-102.7% for the metabolite *** assay recovery was within 95-97% for both the analytes and internal *** method was successfully applied to support a bioequivalence study of 100 mg cilostazol in30 healthy subjects.

关键词： Cilostazol 3 4-dehydro cilostazol UpLC-MS/MS Sensitive High throughput

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