Abstract:
:Highly selective and fast liquid chromatography-tandem mass spectrometric (LC-MS/MS) method was developed and validated for simultaneous determination of tadalafil (TDL) and finasteride (FNS) in human plasma. The method was successfully applied for analysis of TDL and FNS samples in clinical study. The method was validated as per USFDA (United States Food and Drug Administration), EMA (European Medicines Agency), and ANVISA (Agência Nacional de Vigilância Sanitária-Brazil) bio analytical method validation guidelines. Glyburide (GLB) was used as common internal standard (ISTD) for both analytes. The selected multiple reaction monitoring (MRM) transitions for mass spectrometric analysis were m/z 390.2/268.2, m/z 373.3/305.4 and m/z 494.2/369.1 for TDL, FNS and ISTD respectively. The extraction of analytes and ISTD was accomplished by a simple solid phase extraction (SPE) procedure. Rapid analysis time was achieved on Zorbax Eclipse C18 column (50 × 4.6 mm, 5 μm). The calibration ranges for TDL and FNS were 5-800 ng/ml and 0.2-30 ng/ml respectively. The results of precision and accuracy, linearity, recovery and matrix effect of the method are acceptable. The accuracy was in the range of 92.9%-106.4% and method precision was also good; %CV was less than 8.1%.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Pappula N,Kodali B,Datla PVdoi
10.1016/j.jpba.2018.01.020subject
Has Abstractpub_date
2018-04-15 00:00:00pages
215-223eissn
0731-7085issn
1873-264Xpii
S0731-7085(17)32621-3journal_volume
152pub_type
杂志文章abstract::A gas-chromatographic assay method was developed and validated for determination of busulfan in human plasma for test dose therapeutic drug monitoring. Busulfan and the internal standard (1,6-bis-(methanesulfonyloxy)hexane) were extracted from plasma samples and derivatized with 2,3,5,6-tetrafluorothiophenol prior to ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(95)01342-i
更新日期:1995-08-01 00:00:00
abstract::NMR spectroscopy has become an essential diagnostic tool for pharmaceutical preparations worldwide, with many runs performed annually on a routine basis. In this study multivariate analysis was performed on a big dataset of 990 NMR heparin spectra recorded over six years (2012-2017) in our laboratory. Several steps of...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2019.05.024
更新日期:2019-09-05 00:00:00
abstract::A selective and sensitive liquid chromatography-mass spectrometry (LC-MS) method was developed for the simultaneous determination of Euphorbia factor L(1), Euphorbia factor L(2) and Euphorbia factor L(3) from Euphorbiae semen in rat plasma. Larotaxel was added to a 200 μL plasma sample as the internal standard (IS). T...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2012.09.005
更新日期:2013-01-01 00:00:00
abstract::The new approach to drug development, especially for cardiovascular and brain diseases, brought to synthesis of new lipophillic derivatives of strong calcium chelator BAPTA - DP-b99 and DP-109. Due to their chelating ability, these compounds require metal-free stationary phases, and their high hydrophobicity resulted ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(00)00567-7
更新日期:2001-03-01 00:00:00
abstract::A fast and sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed for the determination and pharmacokinetic study of nimodipine in human plasma. With nitrendipine as the internal standard, sample pretreatment involved one-step extraction with diethyl ether of 0.5 m...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2007.10.035
更新日期:2008-02-13 00:00:00
abstract::Four microemulsion liquid chromatography (MELC) systems and one micellar liquid chromatography (MLC) system have been evaluated as potential high-throughput screening platforms capable of modeling the partitioning behaviors of drug compounds in an n-octanol/water system and predicting their lipophilicity (i.e., log P ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2014.09.037
更新日期:2015-01-01 00:00:00
abstract::Besifloxacin is a fourth-generation broad-spectrum fluoroquinolone registered for the topical treatment of bacterial conjunctivitis. In this study, a rapid, sensitive and selective liquid chromatography tandem mass spectrometry (LC-MS/MS) method was developed for quantification of besifloxacin in rabbit plasma and ocu...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2015.08.023
更新日期:2016-01-05 00:00:00
abstract::Salmeterol xinafoate is the first of a new class of long acting, selective beta2-adrenoceptor agonists introduced for the treatment of asthma. The major metabolite of salmeterol in the dog has been identified as the 3-catechol sulphate of the benzoic acid derivative. This metabolite was isolated from dog bile and was ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(98)00114-9
更新日期:1998-11-01 00:00:00
abstract::Over 100 chromatographic procedures for the separation of beta-blocker enantiomers are reviewed including a large number for the analysis of biological samples. All the principal chiral chromatographic procedures have found use, namely Chiral Mobile Phase Additives (CMPA), Chiral Derivatization Agents (CDA) and Chiral...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章,评审
doi:10.1016/0731-7085(92)80057-t
更新日期:1992-06-01 00:00:00
abstract::A simple reversed-phase high-performance liquid chromatography method was developed for the determination of s-carboxymethyl-l-cysteine in syrup preparations. The experiments were performed without specific sample pre-treatment. The LC conditions used were acetonitrile-10 mM sodium dihydrogenphosphate buffer, pH 2.0 (...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(00)00479-9
更新日期:2001-04-01 00:00:00
abstract::Topiroxostat is a recently identified safe and selective xanthine oxidoreductase inhibitor and has been used as a urate-lowing agent for the treatment of hyperuricemia and gout in Japan. In this study, we developed a sensitive, selective and high-throughput method that determines topiroxostat in human plasma using hig...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2020.113470
更新日期:2020-09-10 00:00:00
abstract::A method for the determination of 4-aminophenol as an impurity in paracetamol (N-(4-hydroxyphenyl)-acetamide) by proton nuclear magnetic resonance ((1)H-NMR) spectroscopy has been developed. The (13)C-satellite from the protons in the ortho position from the hydroxyl group in paracetamol was used as an internal standa...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(02)00086-9
更新日期:2002-07-01 00:00:00
abstract::The risk assessment of di(2-ethylhexyl) phthalate (DEHP) that migrated from polyvinyl chloride (PVC) medical devices is an important issue for hospitalized patients. Many studies have been conducted to determine the level of DEHP migration. A recent report has indicated that DEHP in blood bags was hydrolyzed by estera...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2005.06.016
更新日期:2005-10-04 00:00:00
abstract::The flavonoids are a large class of polyphenolic compounds which occur naturally in plants where they are widely distributed. Isovitexin (ISO) is a glycosylated flavonoid that exhibits a potential antioxidant activity. Some recent studies have shown the pharmacokinetic activity of isovitexin in rat blood plasma, howev...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2014.05.015
更新日期:2014-09-01 00:00:00
abstract::The concentration of TiO(2) in a cream formulation has been non-destructively measured using Raman spectroscopy without further sample pretreatments. The distribution of TiO(2) particles in a highly viscous cream may not be homogeneous on a microscopic scale and local aggregation of the particles is possible; therefor...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2010.05.008
更新日期:2010-11-02 00:00:00
abstract::Regulatory guidance requires the quantification of encapsulated and free doxorubicin for a liposomal doxorubicin injection bioequivalence study. Due to the instability of liposome formulations in plasma samples, the release of free drug from the liposomal encapsulated doxorubicin during sample handling would result in...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2020.113388
更新日期:2020-09-10 00:00:00
abstract::A simple HPLC method with UV detection is proposed for the simultaneous determination of three lipophilic vitamins: all-trans-retinol, alpha-tocopherol and coenzyme Q(10) (ubiquinone) in human plasma. The following chromatographic conditions were used: RP-18 column, a mobile phase consisted of methanol -n-hexane 72:28...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.jpba.2006.03.037
更新日期:2006-09-18 00:00:00
abstract::Capillary isotachophoresis (ITP) with conductimetric detection has been used for separating and determining bopindolol (I) in commercial mass-produced pharmaceutical preparations. The optimised operational electrolyte system consisted of 5 mM potassium picolinate and 5 mM picolinic acid (leading electrolyte, LE; pH 5....
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(01)00671-9
更新日期:2002-05-15 00:00:00
abstract::Recently a novel technology, referred to as the 'EPO WGA MAIIA' test, has been developed by Swedish researchers to discriminate between endogenous and recombinant human erythropoietin. In contrast to existing electrophoretic methods that are used by antidoping laboratories, this dipstick-based technique is simple and ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2012.04.025
更新日期:2012-08-01 00:00:00
abstract::The effect of 17 monoamine oxidase inhibitory drugs (propargylamine derivatives) on the phase transition parameters of some synthetic phospholipids has been studied by differential scanning calorimetry. The drugs modified the thermal behaviour of phospholipids proving the existence of phospholipid-drug interactions. P...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(93)80006-m
更新日期:1993-07-01 00:00:00
abstract::A method for analysis of the four stereoisomers of 1045U85 in rat plasma was developed and validated. The method involved liquid extraction of 1045U85 and an internal standard (propranolol) from plasma, followed by reaction with a chiral derivatizing reagent, GITC. The diastereoisomeric products were then separated by...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(94)00077-8
更新日期:1994-11-01 00:00:00
abstract::The evaluation of plasmatic galactosaminoglycans, dermatan sulfate (DS) and chondroitin sulfate (CS) can be helpful in the early identification of MPS patients, also considering that primary storage of one type of GAG can lead to secondary accumulation of other lysosomal substrates. We explore the possibility to deter...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2013.06.026
更新日期:2013-11-01 00:00:00
abstract::A validated stability indicating RP-HPLC assay of doxofylline was developed by separating its related substances and degradants on LichrocartC18 (250 mm × 4.6 mm; 5 μm) column using 10 mM ammonium acetate and acetonitrile as a mobile phase in a gradient mode of elution at a flow rate of 1.0 mL/min at 30 °C. The column...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2013.02.004
更新日期:2013-05-05 00:00:00
abstract::A metabonomic strategy based on UHPLC-MS with principal component analysis was developed to investigate the intervention effects of Epimedium koreanum on metabolism characters of 'Kidney-Yang Deficiency syndrome' rats. The rats were injected intraperitoneally hydrocortisone once daily for 15 days to simulate 'Kidney-Y...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2012.12.022
更新日期:2013-03-25 00:00:00
abstract::An automated on-line SPE and innovative fast polarity switch bioanalysis method employing dual-gradient liquid chromatography (DGLC) coupled with mass spectrometry (DGLC-MS/MS) was established and validated for the simultaneous determination of ferulic acid, ligustrazine and ligustilide in rat plasma after administrat...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2013.08.038
更新日期:2014-01-01 00:00:00
abstract::Quantitative assessment of disease activity is important for effective care of patients with Takayasu arteritis (TA). Activated glutaminolysis and reduced glycolytic flux is the hallmark of active inflammation. Based on this, we hypothesize that the circulatory Glutamine/Glucose ratio (QGR) can serve as an indicant of...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2019.113080
更新日期:2020-02-20 00:00:00
abstract::The absolute majority of the HPLC applications use silica-based columns for the separation of active substance and its impurities. However, stationary phases based on metal oxides appear as an interesting alternative. The aim of our study was to investigate the potential utilization of metal oxide-based stationary pha...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2007.04.027
更新日期:2007-09-03 00:00:00
abstract::Iron is a challenging element due to its high background in various matrixes including blood, tissues even in the air and it is urgent to develop a method for the accurate determination of iron in bio-samples. After optimization of mass spectrometric conditions using collision cell technology and compensating for inte...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2013.08.048
更新日期:2014-01-01 00:00:00
abstract::The lipophilic character of some benzimidazole and benztriazole derivatives was studied. The classical R(Mo) values were compared with the factors scores obtained by principal component analysis (PCA) based also onto the TLC retention data. The very high correlation between the R(Mo) values and slopes (specific hydrop...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(02)00338-2
更新日期:2002-10-15 00:00:00
abstract::A new method for the quantitative analysis by liquid chromatography-tandem mass spectrometry (LC-MS/MS) of five tyrosine kinase inhibitors (afatinib, crizotinib, osimertinib, erlotinib and nintedanib) used in the treatment of non-small cell lung cancer (NSCLC) was developed and validated in human plasma. Separation wa...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2018.05.052
更新日期:2018-09-05 00:00:00