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2篇 您的检索式:作者名="Dharmesh Parmar"
    题名 作者 年代 出处 被引量
1Sensitive and rapid determination of amantadine without derivatization in human plasma by LC–MS/MS for a bioequivalence study显示文摘A highly sensitive, rapid and rugged liquid chromatography-tandem mass spectrometry(LC-ESI-MS/MS)method was developed for reliable estimation of amantadine(AMD), an antiviral drug in human plasma.The analyte and internal standard(IS), amantadine-d6(AMD-d6), were extracted from 200 m L plasma by solid phase extraction on Phenomenex Strata-X-C 33 m cartridges. Chromatography was performed on Synergi? Hydro-RP C18(150 mm ? 4.6 mm, 4 mm) analytical column using a mixture of acetonitrile and10 m M ammonium formate, p H 3.0(80:20, v/v) as the mobile phase. Detection and quantitation was done by multiple reaction monitoring in the positive ionization mode for AMD(m/z 152.1-135.1) and IS(m/z 158.0-141.1) on a triple quadrupole mass spectrometer. The assay was linear in the concentration range of 0.50–500 ng/m L with correlation coefficient(r2) Z 0.9969. The limit of detection of the method was 0.18 ng/m L. The intra-batch and inter-batch precisions were r 5.42% and the accuracy varied from98.47% to 105.72%. The extraction recovery of amantadine was precise and quantitative in the range of97.89%–100.28%. IS-normalized matrix factors for amantadine varied from 0.981 to 1.012. The stability of AMD in whole blood and plasma was evaluated under different conditions. The developed method was successfully applied for a bioequivalence study with 100 mg of AMD in 32 healthy volunteers. The reproducibility of the assay was determined by reanalysis of 134 subject samples.Abhaysingh Bhadoriya Shivprakash Rathnam Bhavesh DasANDi Dharmesh Parmar Mallika Sanyal Pranav S.Shrivastav 2018Journal of Pharmaceutical Analysis2018,8,3:9
2Quantitation of tadalafil in human plasma using a sensitive and rapid LC-MS/MS method for a bioequivalence study显示文摘A highly sensitive liquid chromatography-tandem mass spectrometry(LC-MS/MS) method was developed for the determination of tadalafil(TAD) in human plasma. TAD and its deuterated internal standard(IS), tadalafil-d3, were extracted from 200 mL plasma using Phenomenex Strata-X-C 33 m extraction cartridges. Chromatographic analysis was carried out on Synergi? Hydro-RP C18(100 mm ? 4.6 mm, 4 mm)column with a mobile phase consisting of methanol and 10 m M ammonium formate, p H 4.0(90:10, v/v),delivered at a flow rate of 0.9 m L/min. Quantitation of the protonated analyte was done on a triple quadrupole mass spectrometer using multiple reaction monitoring via electrospray ionization. The precursor to product ions transitions monitored for TAD and TAD-d3 were m/z 390.3-268.2 and m/z393.1-271.2, respectively. The calibration curve was linear over the concentration range of 0.50–500 ng/m L with correlation coefficient, r2 Z 0.9994. Acceptable intra-batch and inter-batch precision(r3.7%) and accuracy(97.8% to 104.1%) were obtained at five concentration levels. The recovery of TAD from spiked plasma was highly precise and quantitative(98.95% to 100.61%). Further, the effect of endogenous matrix components was minimal. TAD was found to be stable under different storage conditions in human plasma and also in whole blood samples. The validated method was successfully used to determine TAD plasma concentration in a bioequivalence study with 20 mg TAD tablets in 24 healthy volunteers. Method performance was evaluated by reanalyzing 115 study samples.Abhaysingh Bhadoriya Bhavesh Dasandi Dharmesh Parmar Priyanka A. Shah Pranav S. Shrivastav 2018Journal of Pharmaceutical Analysis2018,8,4:4
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