Abstract：
:Novel approaches to the development of analytical procedures for monitoring incoming starting material in support of chemical/pharmaceutical processes are described. High technology solutions were utilized for timely process development and preparation of high quality clinical supplies. A single robust HPLC method was developed and characterized for the analysis of the key starting material from three suppliers. Each supplier used a different process for the preparation of this material and, therefore, each suppliers' material exhibited a unique impurity profile. The HPLC method utilized standard techniques acceptable for release testing in a QC/manufacturing environment. An automated experimental design protocol was used to characterize the robustness of the HPLC method. The method was evaluated for linearity, limit of quantitation, solution stability, and precision of replicate injections. An LC-MS method that emulated the release HPLC method was developed and the identities of impurities were mapped between the two methods.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Sheldon EM,Downar JBdoi
10.1016/s0731-7085(00)00333-2subject
Has Abstractpub_date
2000-08-15 00:00:00pages
561-72issue
2-3eissn
0731-7085issn
1873-264Xpii
S0731-7085(00)00333-2journal_volume
23pub_type
杂志文章abstract：:An ultra-sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) assay was developed and validated to facilitate the assessment of clinical pharmacokinetics of nucleotide analogs from lysed intracellular matrix. The method utilized a strong anion exchange isolation of mono-(MP), di-(DP), and tri-phosphates...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.05.039
更新日期：2011-09-10 00:00:00
abstract：:When combating counterfeits it is equally important to recognize fakes and to avoid misclassification of genuine samples. This study presents a general approach to the problem using a newly-developed method called Data Driven Soft Independent Modeling of Class Analogy. The possibility to collect representative data fo...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.05.033
更新日期：2014-09-01 00:00:00
abstract：:Capillary electrophoresis (CE) was applied to the study of several inhibitors of the angiotensin-converting enzyme. Separation of the compounds was performed by means of two phosphate buffers (each 100 mM) at pH 7.0 and 6.25, respectively [S. Hillaert, W. Van den Bossche, J. Chromatogr. A, 895 (2000) 33-42.]. Due to t...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00366-1
更新日期：2001-07-01 00:00:00
abstract：:A sensitive and specific ultra-performance liquid chromatography tandem mass spectrometry (LC-MS/MS) method has been developed for the determination of nicousamide in human plasma. This method has also been validated in terms of selectivity, linearity, lower limit of quantification (LLOQ), accuracy, precision, stabili...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.01.025
更新日期：2013-04-15 00:00:00
abstract：:A high-performance liquid chromatographic method with electrochemical detection is described for the determination of 5-hydroxytryptamine (5-HT) and 5-hydroxyindoleacetic acid (5-HIAA) in brain. Results of studies on sample work-up methods and on the use of various internal standards are reported. The reproducibility ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(88)80108-0
更新日期：1988-01-01 00:00:00
abstract：:The electrochemical oxidation of azithromycin was investigated in order to elucidate the mechanism for possible oxidative metabolic pathways in humans. Electrochemical studies were carried out by cyclic voltammetry and preparative scale electrolysis at glassy carbon electrodes. It was found that azithromycin undergoes...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(03)00315-7
更新日期：2003-11-24 00:00:00
abstract：:A rapid, simple and sensitive liquid chromatography-mass spectrometry (LC-MS) method was developed and validated for the determination of the imidazole H(3) antagonist ROS203 in rat plasma, using the superior homologue ROS287 as internal standard. Analyses were performed on an Agilent 1100 Series HPLC system employing...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.09.010
更新日期：2008-01-07 00:00:00
abstract：:Two UV spectrophotometric methods have been validated for the analysis of hydrolyzed tinidazole solutions. The pH of the samples must be 5.00-7.00 for both methods. The multiwavelength method may be used for samples degraded at pH 6-12 if the amount of conserved 5-nitroimidazole species is at least 93 mol.% of the ori...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00667-2
更新日期：2003-03-10 00:00:00
abstract：:Quantification of virus-like RNA sequences in biological fluids, like serum and cerebrospinal fluid, requires an RNA extraction method that is both reproducible and fast. Three RNA extraction methods were tested on enteroviruses: (1) the acid guanidine thiocyanate-phenol/chloroform (AGPC) method; (2) a method based on...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(03)00312-1
更新日期：2003-11-24 00:00:00
abstract：:The recent interest in RX77368 for the treatment of Motor Neurone Disease (MND) has led to the requirement for an assay (RIA) capable of detecting the peptide at low levels in plasma. Several drug conjugates were prepared in which RX77368 was covalently linked to larger proteins, e.g. bovine serum albumin, keyhole lim...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(91)80230-7
更新日期：1991-01-01 00:00:00
abstract：:A stable isotope dilution liquid chromatography-electrospray ionization tandem mass spectrometry (LC-MS/MS) assay to measure amiodarone, the most frequently used agent for maintaining sinus rhythm in patients with atrial fibrillation, and its major metabolite desethylamiodarone in human plasma and serum was developed....
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.08.004
更新日期：2010-01-05 00:00:00
abstract：:Thin-layer chromatography (TLC) has a myriad of separation applications in chemistry, biology, and pharmacology due to its simplicity and low cost. While benchtop laboratory sample application and detection systems for TLC provide accurate quantitation of TLC spot positions and densities, there are many applications w...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.03.018
更新日期：2016-06-05 00:00:00
abstract：:Pregnane X receptor (PXR) is highly expressed in the liver and plays an integral role in the control of xenobiotic and endobiotic metabolism to maintain homeostasis. We previously reported that activation of PXR significantly induced liver enlargement. But the lipid profiling during PXR-induced hepatomegaly remains un...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113851
更新日期：2021-02-20 00:00:00
abstract：:In this work, an ionic liquid-based ultrasonic-assisted extraction (ILUAE) method was developed to extract caffeoylquinic acids (CQAs) from Flos Lonicerae Japonicae (FLJ). ILUAE parameters were optimized by response surface methodology, including IL concentration, ultrasonic time, and liquid-solid ratio. Optimized ILU...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.12.019
更新日期：2016-02-20 00:00:00
abstract：:Unfractioned Heparins (UFH) and Low Molecular Weight Heparins (LMWHs) are non-chromophoric, high charged sulphated molecules which are difficult to elute and detect with conventional liquid chromatography methods. Moreover, the detection of LMWHs at low concentration level, like in samples coming from dissolution test...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.04.009
更新日期：2008-09-29 00:00:00
abstract：:Applications of capillary electrophoresis (CE) for analysis of phytochemical substances (e.g. flavonoids, alkaloids, terpenoids, phenolic acid, quinones and coumarins) are reviewed. For example, CE analysis of sixteen tea ingredients were achieved within 10 min with the good precision (RSDs% <1% for intra-day and 2% f...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/s0731-7085(01)00531-3
更新日期：2002-02-01 00:00:00
abstract：:Greening analytical methods has become of great interest in the field of pharmaceutical analysis to protect both the operators' health and the environment. In this work, an innovative methodology combining Quality-by-Design (QbD) and Green Chemistry principles was followed to develop a single, green and robust RP-HPLC...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113507
更新日期：2020-10-25 00:00:00
abstract：:Antibiotics are extensively applied in veterinary medicine for the treatment of various bacterial infections. Because of their use in food producing animals, the risk of occurrence of unwanted residues in edible products exists. To ensure human food safety, The European Union has defined maximum residue limits (MRLs) ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(03)00195-x
更新日期：2003-08-08 00:00:00
abstract：:Sampatrilat is a dual inhibitor of angiotensin converting enzyme (ACE) and neutral endopeptidase (NEP) under development for the treatment of hypertension and congestive heart failure. In order to support the early clinical development (with oral administration and an expected low bioavailability), a sensitive and sel...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(97)00127-1
更新日期：1998-01-01 00:00:00
abstract：:Organic solvents such as methanol, acetone, dichloromethane or toluene are frequently used in the pharmaceutical industry. The manufacturing of new active pharmaceutical ingredients (APIs) under GMP conditions commands to control adequately the quality of the different ingredients happening in the synthesis. Organic s...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.06.036
更新日期：2006-02-13 00:00:00
abstract：:A new methodology based on Nuclear Magnetic Resonance (NMR) was developed to determine plasma protein binding (PPB) of drug candidates in drug discovery programs. A strong correlation was found between the attenuation of NMR signals of diverse drugs in the presence of different plasma concentrations and their fraction...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.01.049
更新日期：2019-04-15 00:00:00
abstract：:In this paper, a new and efficient method for synthesis of phloroglucinol with an overall yield of 60% was described. As well, the phloroglucinol association on an immobilized human serum albumin (HSA) column was analyzed in biochromatography by the determination of its Langmuir distribution isotherms. The role of the...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(03)00220-6
更新日期：2003-07-14 00:00:00
abstract：:A novel sensor based on a modification of glassy carbon electrode (GCE) with NH2-functionalized multi-walled carbon nano-tubes (NH2fMWCNTs) is reported and its applicability to the electrochemical sensing of Propafenone (PPF) demonstrated. The electrochemical catalytic activity was also utilized as a sensitive detecti...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.06.026
更新日期：2019-09-10 00:00:00
abstract：:Highly sensitive nanosensors such as graphene oxide/ platinum-iridium nanohybrid, carboxylic acid functionalized multiwalled carbon nanotubes (GO/Pt-Ir/MWCNT-COOH) and amine functionalized multiwalled carbon nanotubes (GO/Pt-Ir/MWCNT-NH2) modified glassy carbon electrode were developed for the determination of 5-hydro...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.05.070
更新日期：2019-09-10 00:00:00
abstract：:The FT-Raman quantification of atorvastatin calcium in tablets was performed using the partial least squares (PLS), principal component regression (PCR) and counter-propagation artificial neural networks (CP-ANN) methods. To compare the predictive abilities of the elaborated models, the relative standard errors of pre...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.10.015
更新日期：2009-01-15 00:00:00
abstract：:A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for evaluating the chiral discrimination ability of CYCLOBOND I 2000 DM chiral stationary phase (CSP) towards sertraline and its related enantiomers. The effect of pH, buffer concentration as well as nature of organic mo...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.04.038
更新日期：2009-10-15 00:00:00
abstract：:An account is given of the development of tests for the bio-assay of insulin and the progress made, at the Wellcome Foundation Limited, during the last 30 years in reducing the number of animals used in the testing of insulin for the treatment of Diabetes Mellitus. The progressive evolution of methods shows how the nu...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/0731-7085(89)80083-4
更新日期：1989-01-01 00:00:00
abstract：:One of the major reasons for age-related cataract formation is an accumulation of insoluble lens proteins. In particular, higher-order α-crystallin aggregates, comprising αA and αB subunits, are insolubilized by the build up of various post-translational modifications over time. Although we previously found an excepti...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.06.017
更新日期：2015-12-10 00:00:00
abstract：:A sensitive reverse phase high performance liquid chromatography-electrospray ionization-mass spectrometry (RP-HPLC-ESI-MS) method has been developed and validated for the determination of hydromorphone in human plasma using naloxone as the internal standard (IS). After alkalization with saturated sodium bicarbonate, ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.11.012
更新日期：2012-03-05 00:00:00
abstract：:Automated column-switching HPLC methods were developed and utilized for the direct analyses of three hydroxamic acid based metalloprotease inhibitors in rat plasma. These column-switching methods involved the use of a restricted-access media (RAM) precolumn and a column-switching valve, allowing the complete automatio...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00127-7
更新日期：1999-03-01 00:00:00
