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Acta Pharmaceutica Sinica B 2015年第5期5卷 482-486页

作者： Yuqiao Song Jie Liao Cheng Zha Bin Wang Charles C.Liu Medical Experiment and Analysis Center of PLA General Hospital ASPEC Technologies Limited Beijing

A novel method for the simultaneous determination of 3-nitrotyrosine(NT) and 3-chlorotyrosine(CT) in human plasma has been developed based on direct analysis in real time–tandem mass spectrometry(DART–MS/MS). Analysis was performed in the positive ionization mode using multiple reaction monitoring(MRM) of the ion transitions at m/z 216.2/170.1 for CT, m/z 227.2/181.1 for NT and m/z 230.2/184.2 for the internal standard, d^3-NT. The assay was linear in the ranges 0.5–100 μg/m L for CT and 4–100 μg/m L for NT with corresponding limits of detection of 0.2 and 2 μg/m L. Intra- and inter-day precisions and accuracies were respectively <15% and ±15%. Matrix effects were also evaluated. The method is potentially useful for high throughput analysis although sensitivity needs to be improved before it can be applied in clinical research.

关键词： 3-Nitrotyrosine 3-Chlorotyrosine Determintion DART–MS/MS human plasma

Development of a Liquid Chromatography-tandem Mass Spectrometry Method for Determination of Butoconazole Nitrate in human plasma and Its Application to a Pharmacokinetic Study

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Journal of Huazhong University of Science and Technology(Medical Sciences) 2014年第3期34卷 431-436页

作者：贾萌萌周莹何晓梦吴义来李虎群谌辉黎维勇 Institute of Clinical Pharmacy Union Hospital Tongji Medical College Huazhong University of Science and Technology

Summary： A liquid chromatography-tandem mass spectrometry （LC-MS/MS） method was developed and validated for the determination of butoconazole in human plasma. human plasma samples of 0.2 μL were pretreated by a single step protein precipitation procedure and analyzed using a high performance liquid chromatography （HPLC） electrospray tandem mass spectrometer system. The compounds were eluted isocratically on an Inertsil ODS-SP column （100 min×2.1 mm, 3 μm）, ionized using a positive ion atmospheric pressure electrospray ionization source and analyzed using multiple reaction monitoring （MRM） mode. The ion transitions monitored were m/z 412.8→q65.1 for butoconazole and m/z 453.4→230.3 for the internal standard. The chromatographic run time was 3.5 min per injection, with retention time of 2.47 rain and 2.15 min for butoconazole and repaglinide, respectively. The method was validated to be linear over the range of 20 to 8000 pg/mL （r〉0.999） by using a weighted （1/x2） quadratic regression. The mean recovery rate was more than 86.7%, and the intra- and inter-day precision of the quality control samples （QCs） was less than 8.3% and the accuracy ranged from 96.0% to 110.2%, which indicated that the quantitative method was reliable and accurate. The method is simple, rapid, and has been applied successfully to a pharmacokinetics study of butoconazole nitrate suppositories in healthy Chinese females.

关键词： liquid chromatography-tandem mass spectrometry human plasma pharmacokinetics bu- toconazole nitrate

A Simple and Sensitive Liquid Chromatographic Technique for the Determination of Cefotetan Disodium in human plasma and Its Application in a Pharmacokinetic Study

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Journal of Huazhong University of Science and Technology(Medical Sciences) 2012年第5期32卷 779-784页

作者：刘亚妮黄建耿刘金梅马林吕永宁师少军 Clinical Trial Organization for Pharmaceutical Products Union HospitalTongji Medical CollegeHuazhong University of Science and Technology Department of Pharmaceutics School of PharmacyTongji Medical CollegeHuazhong University of Science and Technology

A simple and sensitive liquid chromatographic method was developed for quantification of cefotetan disodium (CTT),a semi-synthetic cephamycin antibiotic,in human *** and the internal standard chloramphenicol were extracted from plasma by a simple one-step protein precipitation with 35% (v/v) perchloric *** was carried out on a reverse-phase C18 column with a mobile phase of acetonitile-water containing 0.5% (v/v) phosphoric acids (20:80,v/v) at a flow rate of 1.0 mL/*** column effluent was monitored by UV detection at 300 *** column temperature was maintained at 40°*** method demonstrated good linearity in the range of 0.525-300.0 μg/mL,with correlation coefficients greater than *** limit of quantification (LOQ) was 0.525 μg/mL in human ***-and inter-day precisions were less than 6.63% in terms of relative standard deviation (RSD).The accuracy,when expressed by the bias,ranged from 0.57% to 4.04%.The mean extraction recovery of CTT was higher than 40.94%.The method was found to be precise,accurate,and specific for CTT quantitative analysis,and was successfully applied for a pharmacokinetic study of CTT after a single intravenous dose of 1.0 g of CTT in healthy Chinese subjects.

关键词： cefotetan disodium liquid chromatography human plasma pharmacokinetics

A novel LC–MS/MS assay for methylprednisolone in human plasma and its pharmacokinetic application

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Asian Journal of Pharmaceutical Sciences 2016年第3期11卷 459-468页

作者： Sridhar Siddiraju Mercy Lazar Lal Prasanth Tadiboyina Sirisha Department of Pharmaceutical Chemistry Malla Reddy College of Pharmacy Osmania University Department of Pharmacy Shri Jagdishprasad Jhabarmal Tibrewala University Department of Pharmaceutical Chemistry JSS College of Pharmacy JSS University

Methylprednisolone is a synthetic glucocorticoid. In our report, the authors proposed a sensitive and selective liquid chromatography/tandem mass spectrometry(LC–MS/MS) assay for the determination of methylprednisolone applying budesonide as internal standard. Liquid–liquid extraction(LLE) having tert–butyl methyl ether(TBME) have been employed to extract methylprednisolone from the plasma samples. Immediately after reconstitution, the samples were chromatographed on a C18 column using an isocratic mobile phase composed of 10 m M ammonium formate buffer and acetonitrile(35:65, v/v). A flow rate of 1.00 ml/min was used to elute the analyte form the column. Analysis was carried out with an API–4000 LC–MS/MS instrument operated in multiple reaction-monitoring(MRM) mode. The linearity has been proven within the concentration range of 10.1–804 ng/ml in plasma samples. The precision(%CV) and accuracy results in five validation batches across five concentration levels were well within the acceptance limits. The drug was stable under different conditions. The particular assay has been proficiently put on pharmacokinetic study in healthy male subjects.

关键词： Methylprednisolone human plasma Method validation LC–MS/MS Pharmacokinetics

Determination of lercanidipine in human plasma by an improved UPLC–MS/MS method for a bioequivalence study

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Journal of Pharmaceutical Analysis 2016年第2期6卷 87-94页

作者： Darshan V.Chaudhary Daxesh P.Patel Priyanka A.Shah Jaivik V.Shah Mallika Sanyal Pranav S.Shrivastav Department of Chemistry School of Sciences Gujarat University Navrangpura Ahmedabad Gujarat 380009 India Laboratory of Metabolism Center for Cancer Research National Cancer Institute National Institutes of Health Building 37 Room 3106 Bethesda MD 20892 USA Department of Chemistry St. Xavier's College Navrangpura Ahmedabad Gujarat 380009 India

An improved and reliable ultra-performance liquid chromatography/tandem mass spectrometry （UPLC- MS/MS） method has been developed and validated for the determination of lercanidipine in human plasma. plasma samples with lercanidipine-d3 as an internal standard （IS） were prepared by solid phase extraction on Phenomenex Strata-X cartridges using 100 μL of human plasma. Chromatographic analysis was performed on UPLC BEH C18 （50 mm × 2.1 mm, 1.7 μm） column under isocratic conditions. Linear calibration curves were obtained over a wide dynamic concentration range of 0.010-20.0 ng/mL. Matrix effect was assessed by post-column infusion, post-extraction spiking and standard-line slope methods. The mean extraction recovery was 〉 94% for the analyte and IS. Inter-batch and intra-hatch precision （% CV） across five quality controls was 〈 5.8%. Bioequivalence study was performed with 36 healthy sub- jects after oral administration of 10 mg of lercanidipine and the assay reproducibility was evaluated by reanalysis of 133 incurred samples.

关键词： Lercanidipine UPLC-MS/MS Bioequivalence Solid phase extraction human plasma

Determination of torasemide in human plasma and its bioequivalence study by high-performance liquid chromatography with electrospray ionization tandem mass spectrometry

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Journal of Pharmaceutical Analysis 2016年第2期6卷 95-102页

作者： Lin Zhang Rulin Wang Yuan Tian Zunjian Zhang Key Laboratory of Drug Quality Control and Pharmacovigilance(Ministry of Education) China Pharmaceutical University State Key Laboratory of Natural Medicine China Pharmaceutical University

A sensitive and selective method using high-performance liquid chromatography coupled with elec- trospray ionization tandem mass spectrometry （HPLC-ESI-MS） to determine the concentration of tor- asemide in human plasma samples was developed and validated. Tolbutamide was chosen as the internal standard （IS）. The chromatography was performed on a GI Sciences Inertsil ODS-3 column （100 mm× 2.1 mm i.d., 5.0 μm） within 5 min, using methanol with 10 mM ammonium formate （60：40, v/ v） as mobile phase at a flow rate of 0.2 mL/min. The targeted compound was detected in negative io- nization at m/z 347.00 for torasemide and 269.00 for IS. The linearity range of this method was found to be within the concentration range of 1-2500 ng/mL （r=0.9984） for torasemide in human plasma. The accuracy of this measurement was between 94.05% and 103.86%. The extracted recovery efficiency was from 84.20% to 86.47% at three concentration levels. This method was also successfully applied in pharmacokinetics and bioequivalence studies in Chinese volunteers.

关键词： Torasemide HPLC-ESI-MS human plasma Bioequivalence Pharmacokinetics

Computer Simulation for Effect of Tb^(3+) on Ca^(2+)Speciation in human plasma

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Journal of Rare Earths 2002年第3期20卷 238-240页

作者：卢兴王悦张海元王进平牛春吉倪嘉缵 Chinese Acad Sci Changchun Inst Appl Chem Key Lab Rare Earth Chem & Phys Changchun 130022 Peoples R China

Effect of Tb 3+ on Ca 2+ speciation in human plasma was studied by means of the computer program of MINTEQA2. When Tb 3+ ions are not added into the system, Ca 2+ ions mostly distribute in free Ca 2+ (74.7%) and the surplus distributes in Ca 2+ complexes, such as [CaHCO 3] +(7.9%), [Ca(Lac)] +(6.4%), CaHPO 4 (1 3%), [CaHistidinateThreoninateH 3] 3+ (2.4%), [CaCitrateHistidinateH 2] (2.3%) and CaCO 3(1.1%). Tb 3+ can compete with Ca 2+ for inorganic as well as biological ligands. An increase of concentration of Tb 3+ in the system results in an increase of content of free Ca 2+ and a decrease of contents of Ca 2+ complexes.

关键词： rare earths computer simulation speciation human plasma calcium terbium

Determination of Metformin in human plasma by Liquid Chromatography-tandem Mass Spectrometric Assay

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Chemical Research in Chinese Universities 2005年第2期21卷 246-250页

作者： WANGJian WANGYing-wu GUJing-kai WUYi WANGYan ResearchCenterforDrugMetabolism JilinUniversityChangchun.130023P.R.China

Metformin (1,1-dimethylbiguanide) (Fig. 1) is an oral anti-hyperglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus (type Ⅱ). Owing to its weight-decreasing and serum lipid-normalizing effects, it is especially recommended for obese patients[1,2] Various analytical methods have been described for the measurement of metformin in biological fluids, including gas chromatography(GC)[3-5], capillary electrophoresis (CE)[6] and HPLC[7～16]with UV detection[7-12,17] HPLC-Mass spectrometry (LC/APCIMS/MS ) offers an attractive alternative to HPLC[18].

关键词： Metformin LC-MS-MS human plasma

Determination of 20(S)-protopanaxadiol in human plasma by HPLC–MS/MS:application to a pharmacokinetic study

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Acta Pharmaceutica Sinica B 2013年第6期3卷 385-391页

作者： Feifan Xie Sanwang Li Zeneng Cheng Xingling Liu Hong Zhang Peijiong Li Zhi Liu Xin Guo Peng Yu School of Pharmaceutical Sciences Central South UniversityChangsha 410013China Hunan Tiger-Xiangya R&D Company Ltd. Changsha 410013China

A rapid,specific and sensitive HPLC-MS/MS method was developed and validated for the determination of 20(S)-protopanaxadiol(PPD)in human *** and the internal standard PD were extracted from plasma by liquid-liquid extraction with cyclohexane-methylene dichloride(2:1,v/v).The separation was performed on a HyPURIYTY C18 column using methanol-5 mM ammonium formate(90:10,v/v)as mobile phase at a flow rate of 0.35 mL/*** spectrometric detection was carried out by electrospray ionization(ESI)in the positive ion mode using multiple reaction monitoring(MRM).The monitored transitions were m/z 425.4-217.2 for PPD and at m/z 461.4-425.5 for *** method was linear over the range 0.512-100 ng/mL with a lower limit of quantification(LLOQ)of 0.512 ng/*** mean extraction recovery of PPD was greater than 78.2%and no significant matrix effect was *** intra-and inter-day precisions were less than 10%and the biases below 4%for *** validated method was applied to a three-level single-dose clinical pharmacokinetics study of 12 healthy Chinese volunteers and the main pharmacokinetic parameters of PPD were obtained.

关键词： 20(S)-Protopanaxadiol HPLC–MS/MS human plasma Pharmacokinetics Liquid–liquid extraction

Liquid chromatography electrospray ionization tandem mass spectrometry(LC/ESI-MS/MS) method for quantitative estimation of moxifloxacin in human plasma

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Journal of Chinese Pharmaceutical Sciences 2014年第3期23卷 159-164页

作者： Vipul.M.Vaghela Prajesh Prajapati Hetal K.Patel A.R.College of Pharmacy and G.H.Patel Institute of Pharmacy Institute of Research and Development Gujarat Forensic Sciences University Shree Swaminarayan Sanskar Pharmacy College

A rapid and sensitive liquid chromatography tandem mass spectrometry(LC-MS/MS) method has been developed and validated for the determination of moxifloxacin(MOXI) in human plasma. After a simple protein precipitation using acetonitrile, the post treatment samples were analysed on a C18 column interfaced with a Triple Quadropole Tandem Mass Spectrometer. Positive electrospray ionization was employed as the ionization source. The mobile phase consisted of 0.1% formic acid–acetonitrile(60:40, v/v). Ciprofloxacin(CIPRO) was used as an internal standard. The analyte and internal standard(CIPRO) were monitored in the multiple reaction monitoring mode(MRM). The mass transition ion-pair has been followed as m/z 402→358.2 for MOXI and 332→288.1 for CIPRO. The method was linear in the concentration range of 25–5000 ng/mL. The lower limit of quantification was 25 ng/mL. The intra- and inter-day precision(relative standard deviation) and accuracy(relative error) values were within 12.4%. Each plasma sample was analyzed within 3 min.

关键词： Moxifloxacin Ciprofloxacin human plasma Liquid chromatography tandem mass spectrometry Electrospray ionization