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| 1 | 高效液相色谱-荧光检测法测定人血浆中的匹伐他汀(英文)显示文摘Pitavastatin belongs to the class of coenzyme A reductase inhibitors.Very few methods of assaying pitavastatin from human plasma are available in literature.An analytical method is presented for the determination of the drug from human plasma making use of the fluorescent property of the drug.The drug is extracted from plasma using ethyl acetate under neutral condition and then analyzed by reversed-phase high performance liquid chromatography(HPLC) with fluorescence detection(λEx 245 nm;λEm 420 nm).Analysis of pitavastatin was carried out on a C18 HPLC column using a gradient flow of mobile phase(0.01 mol/L monobasic potassium phosphate(pH 3.20)-acetonitrile,63:37,v/v).Fluorescein isothiocyanate was used as internal standard.The dynamic range of assay was 3 to 50 ng/mL.The intraday precision was less than 10% and accuracy ranged from 95.2% to 112.6%.The same for interday check was less than 12% and 92.8% to 105.1%,respectively.The drug was found to be stable under the assay conditions.The developed method is simple,precise,accurate,and stable.This indicates that it can be applied to routine analysis of this drug in human subjects where there are large numbers of samples without the need of specialized instruments like column switching. | OJHA Ashwini GUTTIKAR Swati VAYEDA Chintan PADH Harish | 2007 | 色谱2007，25，5： | 8 |
| 2 | Development of a sensitive and rapid method for quantitation of (S)-(-)- and (R)-(+)-metoprolol in human plasma by chiral LC–ESI–MS/MS显示文摘A selective, sensitive and high throughput liquid chromatography-tandem mass spectrometry(LC–ESI–MS/MS) method has been developed for separation and quantification of metoprolol enantiomers on a chiral Lux Amylose-2(250 mm 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 of200 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 | Primal Sharma Pritesh Contractor Swati Guttikar Daxesh P.Patel Pranav S.Shrivastav | 2014 | Journal of Pharmaceutical Analysis2014，4，1： | 3 |
| 3 | Simultaneous quantification of prodrug oseltamivir and its metabolite oseltamivir carboxylate in human plasma by LC-MS/MS to support a bioequivalence study显示文摘A simple,precise and rapid liquid chromatography-tandem mass spectrometry(LC-MS/MS) method has been developed and validated for the simultaneous determination of oseltamivir and oseltamivir carboxylate,a neuraminidase inhibitor,using their deuterated analogs as internal standards(ISs).The method involved solid phase extraction of the analytes and ISs from 200 μL human plasma with no reconstitution and drying steps.The chromatographic separation was achieved on a Symmetry C18(100 mm 4.6 mm,5 μm) column using 10 mM ammonium formate and acetonitrile(30:70,v/v) as the mobile phase in a run time of 2.0 min.Quantitation of analytes and ISs were done by multiple reaction monitoring on a triple quadrupole mass spectrometer in the positive ionization mode.The linearity of the method was established in the concentration range of 0.5-200 ng/mL and 2.0-800 ng/mL for oseltamivir and oseltamivir carboxylate respectively.The mean extraction recovery for oseltamivir(94.4%) and oseltamivir carboxylate(92.7%) from spiked plasma samples was consistent and reproducible.The application of this method was demonstratedby a bioequivalence study in 42 healthy Indian subjects with 75 mg oseltamivir phosphate capsules.The assay reproducibility was established by reanalysis of 151 incurred subject samples. | Ajay Gupta Swati Guttikar Pranav S. Shrivastav Mallika Sanyal | 2013 | Journal of Pharmaceutical Analysis2013，3，3： | 3 |
| 4 | High-sensitivity simultaneous liquid chromatography-tandem mass spectrometry assay of ethinyl estradiol and levonorgestrel in human plasma显示文摘A sensitive and simultaneous liquid chromatography-tandem mass spectrometry method was developed and validated for quantification of ethinyl estradiol and levonorgestrel.The analytes were extracted with methyl-tert-butyl ether:n-hexane(50:50,v/v)solvent mixture,followed by dansyl derivatization.The chromatographic separation was performed on a Kinetex C_(18)(50 mm×4.6 mm,2.6 μm)column with a mobile phase of 0.1%(v/v)formic acid in water and acetonitrile in gradient composition.The mass transitions were monitored in electrospray positive ionization mode.The assay exhibited a linear range of 0.100-20.0 ng/mL for levonorgestrel and 4.00-500 pg/mL for ethinyl estradiol in human plasma.A run time of 9.0 min for each sample made it possible to analyze a throughput of more than 100 samples per day.The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic and bioequivalence studies. | Abhishek Gandhi Swati Guttikar Priti Trivedi | 2015 | Journal of Pharmaceutical Analysis2015，5，5： | 1 |
| 5 | Separation of all-trans- and 13-cis-isomers of acitretin on a reversed- phase column, optimization of stability conditions and their simultaneous quantitation in human plasma by liquid chromatography-tandem mass spectrometry 显示文摘 | Sharma P Soni K Guttikar S | 2012 | Anal Methods2012，4，3： | 1 |
| 6 | Chromatographic separation of ( E )- and ( Z )-isomers of entacapone and their simultaneous quantitation in human plasma by LC–ESI-MS/MS显示文摘 | Manish Yadav Pramod Dixit Vikas Trivedi Abhishek Gandhi Arvind Senger Swati Guttikar Puran Singhal Pranav S. Shrivastav | 2009 | Journal of Chromatography B2009，，5： | 1 |
| 7 | Determination of (S) - ( + ) -and (R) - ( - ) -ibuprofen enantiomers in human plasma after chiral precolumn derivatization by reversed- phase LC-ESI-MS/MS 显示文摘 | Sharma P Guttikar S Solanki G | 2012 | Bioanalysis2012，4，24： | 1 |
| 8 | Selective and rapid determination of raltegravir in human plasma by liquid chromatography–tandem mass spectrometry in the negative ionization mode显示文摘A selective and rapid high-performance liquid chromatography–tandem mass spectrometry method was developed and validated for the quantification of raltegravir using raltegravir-d3 as an internal standard(IS). The analyte and IS were extracted with methylene chloride and n-hexane solvent mixture from 100 mL human plasma. The chromatographic separation was achieved on a Chromolith RP-18 e endcapped C18(100 mm 4.6 mm) column in a run time of 2.0 min. Quantitation was performed in the negative ionization mode using the transitions of m/z 443.1-316.1 for raltegravir and m/z 446.1-319.0 for IS. The linearity of the method was established in the concentration range of 2.0–6000 ng/m L.The mean extraction recovery for raltegravir and IS was 92.6% and 91.8%, respectively, and the IS-normalized matrix factors for raltegravir ranged from 0.992 to 0.999. The application of this method was demonstrated by a bioequivalence study on 18 healthy subjects. | Ajay Gupta Swati Guttikar Priyanka A.Shah Gajendra Solanki Pranav S.Shrivastav Mallika Sanyal | 2015 | Journal of Pharmaceutical Analysis2015，5，2： | 0 |
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