Abstract：
:General multistep methods are described for the screening of the chemical and the physical stability and/or reactivity of new drug candidates. The chemical reactivity is studied in aqueous buffer solutions; the rate of degradation is measured as a function of pH. The products of the reaction mixture are evaluated at selected pH-values as a function of time and key reaction products are identified. Strategies for testing degradation products in stability studies are discussed. The purpose of the physical reactivity test is to obtain information on the existing solid-state form in relation to the thermodynamically stable form. A method for finding the stable form is described. When polymorphism is observed a search for additional polymorphs is performed and the different solid phases are characterized. Special tests are described for hydrates and anhydrous forms.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Berglund M,Byström K,Pérsson Bdoi
10.1016/0731-7085(90)80094-6subject
Has Abstractpub_date
1990-01-01 00:00:00pages
639-43issue
8-12eissn
0731-7085issn
1873-264Xpii
0731-7085(90)80094-6journal_volume
8pub_type
杂志文章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：:The electrochemical behavior of piroxicam on a multi-walled carbon nanotubes electrode for the first time was investigated. A highly sensitive and fast responding sensor for determination of piroxicam was simply and conveniently fabricated. The constructed electrode exhibits efficiently catalytic activity for the elec...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.01.027
更新日期：2007-05-09 00:00:00
abstract：:Camazepam [3-(N,N-dimethyl)carbamoyloxy-7-chloro-1-methyl-1, 3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one, CMZ] possesses anxiolytic, anticonvulsant, muscle relaxant and hypnotic properties. CMZ is clinically used as a racemate. The enantioselective metabolism of racemic CMZ by rat liver microsomes was studied. Major...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(93)80103-8
更新日期：1993-11-01 00:00:00
abstract：:A simple and rapid capillary electrophoresis method with UV detection was developed and validated for the determination of rufloxacin hydrochloride in coated tablets. An experimental design strategy (Doehlert design and desirability function) allowed the analytical parameters to be simultaneously optimized in order to...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00054-7
更新日期：2002-06-15 00:00:00
abstract：:A rapid and efficient chiral supercritical fluid chromatography (SFC) method has been developed for the quantitative determination of panthenol enantiomers in cosmetic formulations (cream, lotion, wipe, and exfoliant). Indeed, the pharmacological effect only depends on the D form (Dexpanthenol) thus accurate measureme...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.09.036
更新日期：2015-01-01 00:00:00
abstract：:A combined pH/organic solvent linear gradient mode in high performance liquid chromatography (HPLC) is presented as a new approach to determination of low concentrations of ionogenic analytes in biological material. The approach consists in simultaneous development of linear gradients of pH and organic modifier in the...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.06.031
更新日期：2005-04-29 00:00:00
abstract：:Sunitinib is approved for advanced renal cell cancer, imatinib-resistant or -intolerant gastrointestinal stromal tumors and pancreatic neuroendocrine cancers. It is prescribed at a fixed dose but its plasma exposure shows large inter-individual variations. Taking into account the narrow therapeutic window and the posi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.112949
更新日期：2020-02-05 00:00:00
abstract：:A micellar electrokinetic chromatographic (MEKC) method was developed for the quantification of lovastatin and simvastatin, cholesterol lowering agents in pharmaceutical dosage forms. Lovastatin and simvastatin were separated using an electrolyte system consisting of 12% acetonitrile (v/v) in 25 mM sodium borate buffe...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00128-0
更新日期：2002-07-20 00:00:00
abstract：:In addition to its antifungal activity, clotrimazole attracts interest as an anti-inflammatory drug. In order to correlate this effect with plasma concentrations in mice, a capillary electrophoretic method was developed. Sample preparation was carried out by protein precipitation using methanol. Quantification of clot...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00531-9
更新日期：2003-01-15 00:00:00
abstract：:The interaction of beta-cyclodextrin with a series of structurally related chiral thromboxane antagonists was investigated using NMR and RP-HPLC. HPLC studies used both a cyclodextrin bonded phase (Cyclobond I), and beta-cyclodextrin as a mobile phase additive with an achiral C8 column. Many of the compounds exhibited...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(91)80002-q
更新日期：1991-01-01 00:00:00
abstract：:This paper proposes a method for the validation of chromatography systems in which many experiments to estimate SD or RSD are difficult or impossible to carry out because of time, cost, etc. HPLC systems with UV-Vis and fluorescence detectors and GC-MS system for bisphenol-A leached from hemodialyzers are taken as an ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00698-7
更新日期：2002-05-15 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：:A rugged LC-MS/MS method was developed to quantify reduced and oxidized glutathione (GSH and GSSG, respectively) in rat hepatocytes. In addition, GSH conjugates can be detected, characterized and measured in the same analysis. Samples were treated with acetonitrile and iodoacetic acid to precipitate proteins and trap ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00402-2
更新日期：2001-08-01 00:00:00
abstract：:Alkyl quinolone molecules 2-heptyl-4-quinolone (HHQ) and 2-heptyl-3-hydroxy-4(1H)-quinolone (PQS) are important quorum sensing signals, which play a mediatory role in the pathogenesis of acute and chronic Pseudomonas aeruginosa infection. A targeted approach inhibiting the bacterial 'multiple virulence factor regulon'...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.02.034
更新日期：2017-05-30 00:00:00
abstract：:A gas chromatographic procedure has been developed for the trace determination of chloroacetyl chloride (CAC) and two of its impurities: methyl chloroacetate (MCA) and chloroacetic acid (CAA). All three compounds are derivatized using piperidine in dichloroethane prior to their analysis via gas chromatography coupled ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.09.026
更新日期：2018-01-30 00:00:00
abstract：:A simple and rapid calorimetric method for the determination of 10 sulphonamides as single entities and sulphamethoxazole in combination with trimethoprim without prior separation was developed. The method is based on the reaction of sulphonamide with phenothiazine and N-bromosuccinimide at pH 6 to produce a blue colo...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(88)80043-8
更新日期：1988-01-01 00:00:00
abstract：:A stability-indicating reversed-phase liquid chromatography (LC) method was developed and validated for the determination of lumiracoxib in pharmaceutical formulations. The LC method was carried out on a Synergi fusion C(18) column (150 mmx4.6mm), maintained at 30 degrees C. The mobile phase was composed of phosphoric...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.09.008
更新日期：2010-02-05 00:00:00
abstract：:The diffusion of drug residues in wastewaters and surface waters as rivers and streams may constitute a problem for the environment, with consequences on the ecosystem and also on the human health. This paper deals with the study of the photo-induced transformation of amiloride, an orally administered diuretic agent, ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.01.014
更新日期：2008-09-29 00:00:00
abstract：:Dried blood spot (DBS) sampling was investigated as a means of obtaining micro-volume blood samples for the quantitative analyses of ten commonly UK prescribed cardiovascular drugs as an indicator of medication adherence. An 8mm disc was punched out from each DBS from calibration, quality control and volunteer samples...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.04.045
更新日期：2017-08-05 00:00:00
abstract：:In this brief review a superficial introduction is given to the important area of biologically active carbohydrates. The complexity of carbohydrate chemistry is considered and the possible uses of carbohydrates as drugs and diagnostic agents are outlined. The analytical tools and methods that are especially useful for...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(86)80007-3
更新日期：1986-01-01 00:00:00
abstract：:A rapid, selective and sensitive isocratic reversed-phase HPLC assay coupled with MS/MS detection for simultaneous quantification of fluoxetine and its major active metabolite in serum samples has been developed. Analytes were extracted with a simple three step liquid-liquid procedure and chromatographic separation wa...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.11.017
更新日期：2009-02-20 00:00:00
abstract：:A high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, using hydrophilic interaction liquid chromatography (HILIC) chromatography for the analysis of fosfomycin in human plasma and urine, has been developed and validated. The plasma method uses a simple protein precipitation using a low v...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.11.042
更新日期：2015-02-01 00:00:00
abstract：:A rapid and sensitive method for determination of ascaridole in rat plasma was developed based on gas chromatography-mass spectrometry (GC/MS). The analyte and internal standard (IS), naphthalene, were extracted from plasma with ethyl acetate and then separated by GC on a HP-5MS capillary analytical column (30 m x 0.2...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.06.017
更新日期：2008-11-04 00:00:00
abstract：:The pharmacokinetics and pharmacodynamics (PK/PD) of imidaprilat, an active metabolite of imidapril, a new angiotensin-converting enzyme (ACE) inhibitor, were investigated. Imidapril was infused subcutaneously for 4 weeks via an osmotic pump implanted under the skin in the back of male spontaneously hypertensive rats ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(96)02015-8
更新日期：1997-08-01 00:00:00
abstract：:The microwave-assisted ionic liquid homogeneous liquid-liquid microextraction (MA-IL-HLLME) coupled with high performance liquid chromatography with diode array detection (HPLC-DAD) was developed for the determination of anthraquinones, including aloe-emodin, emodin, chrysophanol and physcion in root of Rheum palmatum...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.03.046
更新日期：2016-06-05 00:00:00
abstract：:Salvianolic acid B (SAB), tanshinone IIA (TS), ginsenoside Rb₁ (Rb₁), ginsenoside Rg₁ (Rg₁) and notoginsenoside R₁ (R₁) are major active ingredients of Fufang Danshen preparation (FDP) for its protective effects on myocardial ischemia. This study investigated the pharmacokinetics of marker compounds after oral adminis...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.03.058
更新日期：2012-08-01 00:00:00
abstract：:Cloud-point extraction (CPE) is attracting increasing interest in a number of analytical fields, including bioanalysis, as it provides a simple, safe and environmentally-friendly sample preparation technique. However, there are only few reports on the application of this extraction technique in liquid chromatography-e...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.05.042
更新日期：2016-09-05 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：:Because of its essential role in SDS-PAGE, sodium dodecylsulphate (SDS) is generally associated with protein denaturation. However, for SDS-PAGE, proteins are linearized in the presence of SDS, following the exposure to high temperatures and reducing agents. In comparison, the conditions employed during a capillary el...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.07.033
更新日期：2012-12-01 00:00:00
abstract：:Determination of the chiral composition of drugs is nowadays a key step in order to determine purity, activity, bioavailability, biodegradation, etc., of pharmaceuticals. In this article, works published for the last 5 years on the analysis of chiral drugs by liquid separation techniques coupled with mass spectrometry...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2005.10.044
更新日期：2006-02-24 00:00:00
