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Journal of Pharmaceutical Analysis 2015年第5期5卷 316-326页

作者： Abhishek Gandhi swati guttikar Priti Trivedi Bioanalytical Research Veeda Clinical Research Department of Pharmaceutical Chemistry K.B.Institute of Pharmaceutical Education and Research Department of Pharmaceutical Chemistry K.B. Institute of Pharmaceutical Education and Research

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 Cla （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.

关键词： Ethinyl estradiolLevonorgestrelLC-MS]MSHuman plasmaDerivatization

Simultaneous quantification of prodrug oseltamivir and its metabolite oseltamivir carboxylate in human plasma by LC-MS/MS to support a bioequivalence study

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Journal of Pharmaceutical Analysis 2013年第3期3卷 149-160页

作者： Ajay Gupta swati guttikar Pranav S. Shrivastav Mallika Sanyal Chemistry Department Kadi Sarva Vishwavidyalaya Sarva Vidyalaya Campus Sector 15/23Gandhinagar 382015 India Bioanalytical Research Department Veeda Clinical ResearchAmbawadiAhmedabad 380015 India Department of Chemistry School of Sciences Gujarat UniversityAhmedabad 380009 India Chemistry Department St. Xavier's CollegeNavrangpuraAhmedabad 380009 India

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.

关键词： Oseltamivir Oseltamivir carboxylate LC-MS/MS Human plasma Bioequivalence study

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

Selective and rapid determination of raltegravir in human plasma by liquid chromatography–tandem mass spectrometry in the negative ionization mode

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Journal of Pharmaceutical Analysis 2015年第2期5卷 101-109页

作者： Ajay Gupta swati guttikar Priyanka A.Shah Gajendra Solanki Pranav S.Shrivastav Mallika Sanyal Chemistry Department Kadi Sarva Vishwavidyalaya Sarva Vidyalaya Campus Sector 15/23 Bioanalytical Research Department Veeda Clinical Research Department of Chemistry School of Sciences Gujarat University Department of Chemistry St.Xavier’s College

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 *** 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.

关键词： Raltegravir LC–ESI–MS/MS Negative ionization mode Human plasma Bioequivalence study

高效液相色谱-荧光检测法测定人血浆中的匹伐他汀(英文)

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色谱 2007年第5期25卷 715-718页

作者： OJHA Ashwini guttikar swati VAYEDA Chintan PADH Harish B.V.Patel Pharmaceutical Education & Research Development(PERD) CentreAhmedabadGujaratIndia

Pitavastatin belongs to the class of coenzyme A reductase *** few methods of assaying pitavastatin from human plasma are available in *** analytical method is presented for the determination of the drug from human plasma making use of the fluorescent property of 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 *** dynamic range of assay was 3 to 50 ng/*** 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%,*** drug was found to be stable under the assay *** developed method is simple,precise,accurate,and *** 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.

关键词：血浆高效液相色谱激发荧光异硫氰酸荧光素四伐他汀钙