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Rapid quantification of the metabolite of valacyclovir hydrochloride in human plasma by liquid chromatography-tandem mass spectrometry

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Journal of Pharmaceutical Analysis 2010年第2期22卷 83-90页

作者： Yuan Tian1,2,Hui Lin1,2,Xue-Yu Zhang1,2,Zun-Jian Zhang1,2,Guo-Guang Mao31. Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University),Ministry of Education,Nanjing 210009 2. Center for Instrumental Analysis,China Pharmaceutical University,Nanjing 210009 3. Department of Clinical Pharmacology,Wannan Medical College,Wuhu 241000,China. Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University) Ministry of Education Nanjing 210009 China Center for Instrumental Analysis China Pharmaceutical University Nanjing 210009 China Department of Clinical Pharmacology Wannan Medical College Wuhu 241000 China

Objective To establish a rapid,sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of acyclovir (the metabolite of valacyclovir hydrochloride) in human plasma. Methods After addition of ganciclovir as internal standard (IS),plasma samples were prepared by one-step protein precipitation using acetonitrile as precipitant,followed by an isocratic elution with 0.1% formic acid solution-methanol (95∶5,v/v) on an Agilent ZORBAX SB-C18 (150mm×2.1mm i.d.,3.5μm) column. Detection was performed on a triple-quadrupole mass spectrometer utilizing electrospray ionization (ESI) interface operating in positive ion and selected reaction monitoring (SRM) mode with the precursor to product ion transitions m/z 226.2→152.1 for acyclovir and m/z 256.2→152.1 for the IS. Results The analytical results demonstrated a good linearity over the ranges from 0.005 to 4μg/mL (r=0.9999) for valacyclovir hydrochloride. The relative standard deviations (RSD) of intra-batch and inter-batch were less than 4.06% and 9.23%,respectively. The limit of detection and lower limit of quantification in human plasma were 2ng/mL and 5ng/mL,respectively. Conclusion The method was simple,sensitive,accurate and reproducible and has been successfully applied to a bioequivalence study of valacyclovir hydrochloride capsules in Chinese healthy male volunteers.

关键词： valacyclovir hydrochloride acyclovir liquid chromatography-tandem mass spectrometry method validation human plasma

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Simultaneous determination of atorvastatin,metformin and glimepiride in human plasma by LC-MS/MS and its application to a human pharmacokinetic study

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Journal of Pharmaceutical Analysis 2013年第1期3卷 9-19页

作者： Srinivasa Rao Polagani Nageswara Rao Pilli Ramakrishna Gajula Venkateswarlu Gandu Research Studies Rayalaseema University Wellquest Clinical Research Department of Chemistry Nizam CollegeOsmania University

A simple, rapid and sensitive liquid chromatography-tandem mass spectrometric （LC MS/ MS） assay method has been developed and fully validated for the simultaneous quantification of atorvastatin, metformin and g.）imepiride in human plasma. Carbamazepine was used as internal standard （IS）. The analytes were extracted from 200 μL aliquots of human plasma via protein precipitation using acetonitrile, The reconstituted samples were chromatographed on a Alltima HP C18 column by using a 60：40 （v/v） mixture of acetonitrile and 10 mM ammonium acetate （pH 3.0） as the mobile phase at a flow rate of 1.1 mL/min. The calibration curves obtained were linear （r2〉0.99） over the concentration range of 0.50-150.03 ng/mL for atorvastatin, 12.14-1207.50 ng/mL for metformin and 4.98-494.29 ng/mL for glimepiride. The API-4000 LC-MS/MS in multiple reaction monitoring （MRM） mode was used for detection. The results of the intra- and inter-day precision and accuracy studies were well within the acceptable limits. All the analytes were found to be stable in a battery of stability studies. The method is precise and sensitive enough for its intended purpose. A run time of 2.5 rain for each sample made it possible to analyze more than 300 plasma samples per day. The developed assay method was successfully applied to a pharmacokinetic study in human male volunteers.

关键词： Atorvastatin Metformin Glimepiride LC-MS/MS human plasma Pharmacokinetics

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Quantification of sibutramine and its two metabolites in human plasma by LC-ESI-MS/MS and its application in a bioequivalence study

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Journal of Pharmaceutical Analysis 2012年第4期2卷 249-257页

作者： Venkata Suresh Ponnuru B.R.Challa RamaRao Nadendla Chalapathi Institute of Pharmaceutical Sciences Krishna University Nirmala College of Pharmacy

Obesity can be considered as a chronic illness of epidemic proportion and its incidents have increased exponentially in recent *** use of anti-obesity drugs such as sibutramine is somewhat *** is a need to quantify such drugs in biological samples,which is generally quite *** this report,we developed and validated a simple,sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantification of sibutramine (SB) and its two metabolites N-des methyl sibutramine (DSB) and N-di desmethyl sibutramine (DDSB) in human *** SBC18 (4.6 mm × 75 mm,3.5 μm,80 (A)) analytical column and 5 mM ammonium formate:acetonitrile (10∶90,v/v) mobile phase were used for chromatographic separation of SB,DSB and *** reaction monitoring (MRM) in the positive mode was used to detect SB,DSB and DDSB at m/z 280.3/124.9,266.3/125.3 and 252.2/124.9,*** liquid extraction was used for the extraction of analytes and internal standard from human *** method was validated over a linear concentration range of 10.0-10,000.0 pg/mL for SB,DSB and DDSB with correlation coefficients (r) of ≥*** drug and the two metabolites were stable in plasma *** validated method was successfully applied in a bioequivalence and pharmacokinetic study with human volunteers under fasting condition.

关键词： LC–ESI-MS/MS Sibutramine human plasma Bioequivalence Pharmacokinetic study

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Validated LC-MS/MS method for simultaneous determination of SIM and its acid form in human plasma and cell lysate: Pharmacokinetic application

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Journal of Pharmaceutical Analysis 2012年第6期2卷 403-411页

作者： Tamer A. Ahmed Jamie Horn John Hayslip Markos Leggas Department of Pharmaceutical Sciences College of Pharmacy University of Kentucky Markey Cancer Center University of Kentucky

Simvastatin （SIM） is a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor widely used in hyperlipidemia therapy. SIM has recently been studied for its anticancer activity at doses higher than those used for the hyperlipidemia therapy. This prompted us to study the pharmacokinetics of high-dose SIM in cancer patients. For this purpose, an LC-MS/MS method was developed to measure SIM and its acid form （SIMA） in plasma and peripheral blood mononuclear cells （PBMCs） obtained from patients. Chromatographic analyte separation was carried out on a reverse-phase column using 75：25 （% v/v） acetonitrile：ammonium acetate （0.1 M, pH 5.0） mobile phase. Detection was performed on a triple quadrupole mass spectrometer, equipped with a turbo ion spray source and operated in positive ionization mode. The assay was linear over a range 2.5-500 ng/mL for SIM and 5-500 ng/mL for SIMA in plasma and 2.5-250 ng/mL for SIM and 5-250 ng/mL for SIMA in cell lysate. Recovery was 〉 58% for SIM and 〉 75% for SIMA in both plasma and cell lysate. SIM and SIMA were stable in plasma, cell lysate and the reconstitution solution. This method was successfully applied for the determination of SIM and SIMA in plasma and PBMCs samples collected in the pharmacokinetic study of high-dose SIM in cancer patients.

关键词： Simvastatin LC-MS/MS human plasma Cell lysate Pharmacokinetic High-dose

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Quantitation of bivalirudin,a novel anticoagulant peptide,in human plasma by LC-MS/MS:Method development,validation and application to pharmacokinetics

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Journal of Pharmaceutical Analysis 2013年第1期3卷 1-8页

作者： Xiao-Jiao Li Yan-Tong Sun Lei Yin Xue-Ju Zhang Yan Yang J.Paul Fawcett Yi-Min Cui Jing-Kai Gu Clinical Pharmacology Center Research Institute of Translational MedicineThe First Bethune Hospital of Jilin University Research Center for Drug Metabolism College of Life ScienceJilin University School of Pharmacy University of Otago Department of Pharmacy Peking University First Hospital

A rapid and sensitive method based on liquid chromatographtandem mass spectrometry （LC-MS/MS） for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. plasma samples were precipitated protein with acetonitrile and reextracted with dichloromethane, after which the analyte and triptorelin as an internal standard （IS） were separated on a 300SB-Cl8 column （150 mm x 4.6 mm i.d., 5 gm particle size） using 0.1% formic acid：methanol （45：55, v/v） as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization （ESI） interface, was operated in the positive ion mode, and the multiplereaction monitoring （MRM） transitions of bivalirudin and IS were at m/z 1091.0-650.4 and m/z656.5 - 249.3, respectively. The lower limit of quantification （LLOQ） was 1 ng/mL for 100 ng/mL plasma sample and the assay was linear over the concentration range 1 1000 ng/mL. The accuracy was within a range from -0.4% to 0.5% in terms of relative error （RE） and the intra- and inter-day precisions in terms of relative standard deviation （RSD） were 〈2.92 and 〈 3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin （0.5 mg/kg） to Chinese volunteers.

关键词： Bivalirudin LC-MS/MS Pharmacokinetics human plasma Anticoagulant

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High performance liquid chromatography mass spectrometric method for the simultaneous quantification of pravastatin and aspirin in human plasma:Pharmacokinetic application

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Journal of Pharmaceutical Analysis 2012年第3期2卷 206-213页

作者： Srinivasa Rao Polagani Nageswara Rao Pilli Venkateswarlu Gandu Research Studies Rayalaseema UniversityKurnool 518002India University College of Pharmaceutical Sciences Jawaharlal Nehru Technological UniversityKukatpallyHyderabad 500085India Department of Chemistry Nizam CollegeOsmania UniversityHyderabad 500001India

A rapid and sensitive liquid chromatography-tandem mass spectrometric（LC-MS/MS） assay method has been developed and fully validated for the simultaneous quantification of pravastatin and aspirin in human *** was used as an internal *** and the internal standard were extracted from human plasma by liquid-liquid extraction technique using methyl tertiary butyl *** reconstituted samples were chromatographed on a Zorbax SB-C;8 column by using a mixture of 5 mM ammonium acetate buffer and acetonitrile（20:80,v/v） as the mobile phase at a flow rate of 0.8 mL/*** calibration curve obtained was linear（r≥0.99） over the concentration range of 0.50-600.29 ng/mL for pravastatin and 20.07-2012.00 ng/mL for *** validation was performed as per FDA guidelines and the results met the acceptance criteria.A run time of 2.0 min for each sample made it possible to analyze more than 400 human plasma samples per *** proposed method was found to be applicable to clinical studies.

关键词： Pravastatin Aspirin human plasma Liquid-liquid extraction LC-MS/MS Pharmacokinetics

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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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A sensitive, simple and rapid HPLC–MS/MS method for simultaneous quantification of buprenorpine and its N-dealkylated metabolite norbuprenorphine in human plasma

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Journal of Pharmaceutical Analysis 2013年第4期3卷 221-228页

作者： Yi-Ya Wang Xiao-Hang Shen Hao Li Feng-Ju Chen Yan Fu Li Ding Department of Pharmaceutical Analysis China Pharmaceutical University Bioanalytical Service WuXi AppTec Co. Ltd.

A sensitive, simple and rapid high performance liquid chromatography-tandem mass spectrometry （HPLC-MS/MS） method was developed and fully validated for the simultaneous quantification of buprenorphine （BUP） and its N-dealkylated metabolite norbuprenorphine （NBUP） in 200 μL human plasma. human plasma samples were prepared using liquid-liquid extraction, and then separated on a Shiseido MG C18 （5 μm, 2.0 mm × 50 mm） via 4.1 min gradient elution. Following electrospray ionization, the analytes were quantified on a triple-quadrupole mass spectrometer in multiple-reaction-monitoring （MRM） positive ion mode. Linearity was achieved from 25.0 to 10000 pg/mL for buprenorphine, from 20.0 to 8000 pg/mL for norbupre- norphine with r2〉0.99. The method was demonstrated with acceptable accuracy, precision and specificity for the detection of buprenorphine and norbuprenorphine. Recovery was 81.8-88.8 % for buprenorphine and 77.0-84.6% for norbuprenorphine, and the matrix effect was 95.6-97.4% for buprenorphine and 94.0-96.9% for norbuprenorphine; all were not concentration dependent. With validated matrix and autosampler stability data, this method was successfully applied in a bioequivalence study to support abbreviated new drug application.

关键词： Buprenorphine Norbuprenorphine human plasma HPLC-MS/MS

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Simultaneous determination of telmisartan and amlodipine in human plasma by LC-MS/MS and its application in a human pharmacokinetic study

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Journal of Pharmaceutical Analysis 2012年第5期2卷 319-326页

作者： Vasu Babu Ravi Jaswanth Kumar Inamadugu Nageswara Rao Pilli Vudagandla Sreenivasulu Venkateswarlu Ponneri Research Studies Rayalaseema UniversityKurnool 518002India Wellquest Clinical Research Laboratories RamanthapurHyderabad 500013India BioPolymer and Thermophysical Lab Department of ChemistrySri Venkateswara UniversityTirupati 517502India Analytical and Environmental Chemistry Division Department of ChemistrySri Venkateswara UniversityTirupati 517502India

A rapid and sensitive liquid chromatography-tandem mass spectrometric （LC-MS/MS） assay method has been developed and fully validated for the simultaneous quantification of telmisartan and amlodipine in human plasma. Carbamazepine was used as an internal standard. Analytes and the internal standard were extracted from human plasma by solid-phase extraction technique using Waters Oasis HLB 1 cm3 （30 mg） extraction cartridge. The reconstituted samples were chromatographed on a Hypurity advance C18 column （50mm × 4.6mm, 5 gm） using a mixture of acetonitrile -5 mM ammonium acetate buffer （pH-4.0）（50：50, v/v） as the mobile phase at a flow rate of 0.8mL/min. The calibration curve obtained was linear （r_〉0.99） over the concentration range of 2.01-400.06 ng/mL for telmisartan and 0.05 -10.01 ng/mL for amlodipine. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 400 human plasma samples per day. The proposed method was found to be applicable to clinical studies.

关键词： Telmisartan Amlodipine human plasma Solid-phase extraction LC-MS/MS Pharmacokinetics

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Simultaneous determination of pioglitazone and candesartan in human plasma by LC-MS/MS and its application to a human pharmacokinetic study

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Journal of Pharmaceutical Analysis 2012年第3期2卷 167-173页

作者： Vijaya Kumari Karra Nageswara Rao Pilli Jaswanth Kumar Inamadugu J.V.L.N.Seshagiri Rao University College of Pharmaceutical Sciences Jawaharlal Nehru Technological UniversityKukatpallyHyderabad-500085India Analytical and Environmental Chemistry Division Department of ChemistrySri Venkateswara UniversityTirupati-517502India College of Pharmaceutical Sciences Andhra UniversityVisakhapatnam-530003India

A simple and rapid liquid chromatography-tandem mass spectrometric(LC-MS/MS) assay method has been developed and fully validated for simultaneous quantification of pioglitazone and candesartan in human *** was used as an internal *** analytes were extracted from human plasma samples by solid-phase extraction technique using a Strata-X 33 mm polymeric *** reconstituted samples were chromatographed on a C18 column by using a 80:20(v/v) mixture of acetonitrile and 0.1% formic acid as the mobile phase at a flow rate of 0.8 mL/*** calibration curves obtained were linear(rZ0.99) over the concentration range of 15-3000 ng/mL for pioglitazone and 5-608 ng/mL for *** results of the intra-and inter-day precision and accuracy studies were well within the acceptable limits.A run time of 2.7 min for each sample made it possible to analyze more than 300 plasma samples per *** proposed method was found to be applicable to clinical studies.

关键词： Pioglitazone Candesartan human plasma Solid-phase extraction LC-MS/MS Pharmacokinetics

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