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Liquid chromatography-tandem mass spectrometry method for the estimation of adefovir in human plasma:Application to a pharmacokinetic study

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Journal of Pharmaceutical Analysis 2015年第3期5卷 190-199页

作者： Dipanjan Goswami sanjay gurule Arabinda Saha Poonam Vats Arshad Khuroo Tausif Monif Sun Pharmaceutical industries Ltd. Department of Clinical Pharmacology and Pharmacokinetics Ranbaxy LaboratoriesLtd.

An analytical method based on solid phase extraction was developed and validated for analysis of adefovir in human plasma. Adefovir-d4 was used as an internal standard and Synergi MAX RP80A （150rnmx4.6mm. 41am） column provided the desired chromatographic separation of compounds followed by detection with mass spectrometry. The method used simple isocratic chromato- graphic condition and mass spectrometric detection in the positive ionization mode. The calibration cuives were linear over the range of 0.50-42.47 ng/mL with the lower limit of quantitation validated at 0.50 ng/mL. Matrix effect was assessed by post-column infusion experiment to monitor phospholipids and post- extraction addition experiment was performed. The degree of matrix effect for adefovir was determined as 7.5% and ion-enhancement in five different lots of human plasma was 7.1% and had no impact on study samples analysis with 4.5 rain run time. The intra- and inter-day precision values were within 7.7% and 7.8%, respectively, for adefovir at the lower limit of quantification level. Validated bioanalytical method was successfully applied to clinical sample analysis.

关键词： Liquid chromatography-tandem massspectrometry Solid phase extraction Pharmacokinetic study

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Simultaneous quantitation of atorvastatin and its two active metabolites in human plasma by liquid chromatography/(–) electrospray tandem mass spectrometry

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Journal of Pharmaceutical Analysis 2014年第1期4卷 26-36页

作者： Pankaj Partani S.Manaswita Verma sanjay gurule Arshad Khuroo Tausif Monif Department of Clinical Pharmacology and Pharmacokinetics Ranbaxy Research Laboratories Plot: GP-5 Sec-18 HSIIDC Department of Pharmaceutical Sciences Birla Institute of Technology

A sensitive, accurate and selective liquid chromatography-tandem mass spectrometry method （LC-MS/MS） was developed and validated for the simultaneous quantitation of atorvastatin （AT） and its equipotent hydroxyl metabolites, 2-hydroxy atorvastatin （2-AT） and 4-hydroxy atorvastatin （4-AT）, in human plasma. Electrospray ionization （ESI） interface in negative ion mode was selected to improve the selectivity and the sensitivity required for this application. Additionally, a solid phase extraction （SPE） step was performed to reduce any ion-suppression and/or enhancement effects. The separation of all compounds was achieved in less than 6 min using a C18 reverse-phase fused-cores column and a mobile phase, composed of a mixture of 0.005%formic acid in water：acetonitrile：methanol （35：25：40, v/v/v）, in isocratic mode at a flow rate of 0.6 mL/min. The method has lower limit of quantitation （LLOQ） of 0.050 ng/mL for all analytes. The method has shown tremendous reproducibility, with intra-and inter-day precision less than 6.6%, and intra- and inter-day accuracy within 74.3% of nominal values, for all analytes, and has proved to be highly reliable for the analysis of clinical samples.

关键词： Atorvastatin LC-MS/MS Solid phase extractionPharmacokinetics Method validation

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Liquid chromatography tandem mass spectrometry method for the estimation of lamotrigine in human plasma:Application to a pharmacokinetic study

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Journal of Pharmaceutical Analysis 2013年第2期3卷 75-83页

作者： Santosh Ghatol Vatsal Vithlani sanjay gurule Arshad Khuroo Tausif Monif Pankaj Partani Department of Clinical Pharmacology and Pharmacokinetics Ranbaxy Research LaboratoriesPlot:GP-VSec-18HSIIDCGurgaon 122015HaryanaIndia

A reliable,selective and sensitive liquid chromatography tandem mass spectrometry method was developed and validated for the quantification of lamotrigine in human plasma using lamotrigine13C3,d3 as an internal *** and internal standard were extracted from human plasma by solid-phase extraction and detected in positive ion mode by tandem mass spectrometry with electrospray ionization（ESI） *** separation was performed on a Chromolith s SpeedROD;RP-18e column（50-4.6 mm i.d.） using acetonitrile：570.1 mM ammonium formate solution（90：10,v/v） as the mobile phase at a flow rate of 0.500 mL/*** calibration curves were linear over the range of 5.02-1226.47 ng/mL with the lower limit of quantitation validated at 5.02 ng/*** analytes were found stable in human plasma through three freeze（-20℃）-thaw（ice-cold water bath） cycles and under storage on bench-top in ice-cold water bath for at least 6.8 h,and also in the mobile phase at 10℃ for at least *** method has shown good reproducibility,as the intra-and inter-day precisions were within 3.0%,while the accuracies were within 76.0% of nominal *** validated LC-MS/MS method was applied for the evaluation of pharmacokinetic and bioequivalence parameters of lamotrigine after an oral administration of 50mg lamotrigine tablet to thirty-two healthy adult male volunteers.

关键词： Lamotrigine Liquid chromatography/tandem mass spectrometry Solid phase extraction Pharmacokinetic study

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