Abstract：
:A dissolution method with high performance liquid chromatography (HPLC) analysis was validated for an immediate release low dose tablet formulation. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, precision, linearity, accuracy and range. Validation of precision included an intermediate precision study using an experimental design in order to satisfy Japanese regulatory requirements. In addition, filter suitability, standard and sample solution stability and method robustness were demonstrated. A statistical design of experiments was used for the robustness evaluation of both the dissolution method and the HPLC analysis method. All results were acceptable and confirmed that the method is suitable for its intended use.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Space JS,Opio AM,Nickerson B,Jiang H,Dumont M,Berry Mdoi
10.1016/j.jpba.2007.04.032subject
Has Abstractpub_date
2007-09-03 00:00:00pages
1064-71issue
5eissn
0731-7085issn
1873-264Xpii
S0731-7085(07)00258-0journal_volume
44pub_type
杂志文章abstract：:Astemizole (AST), a second-generation antihistamine, is metabolized to desmethyl astemizole (DEA), and although it has been removed from the market for inducing QT interval prolongation, it has reemerged as a potential anticancer and antimalarial agent. This report describes a novel high-performance liquid chromatogra...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.04.036
更新日期：2015-10-10 00:00:00
abstract：:In a preliminary study pyroglutamate showed to be over 10 times increased in some lyophilised coffees with respect to brewed or filtered coffees, and probably that increase is related to some stage of the industrial process. Pyroglutamate is known to have a number of remarkable cognitive enhancing effects, which could...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2006.01.062
更新日期：2006-06-16 00:00:00
abstract：:Substandard antimalarial drugs will result in unsatisfied therapeutic efficacy and increase the risk of resistance development. The point-of-care, qualitative, or semi-quantitative dipstick immunoassays cannot differentiate the substandard drugs with confidence. A rapid and quantitative analytical method that can be u...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113605
更新日期：2020-11-30 00:00:00
abstract：:Free D-aspartate and D-serine occur at substantial levels in the mammalian brain. D-Serine is a physiological endogenous co-agonist for synaptic N-Methyl D-Aspartate (NMDA) receptors (NMDARs), and is involved in the pathophysiology of schizophrenia. Much less is known about the biological meaning of D-aspartate. D-Asp...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2015.03.024
更新日期：2015-12-10 00:00:00
abstract：:A simple, rapid, reliable and highly sensitive on-line two-dimensional reversed-phase liquid chromatography-tandem mass spectrometric (2D-LC/MS/MS) method to determine antiretroviral drugs viz., abacavir (ABC), nevirapine (NVP) and indinavir (IDV) in rat serum and urine was developed and validated. The analytes were e...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.07.005
更新日期：2009-12-05 00:00:00
abstract：:One of the first examples of a bienzymatic organic phase enzyme electrode (OPEE) is described. It was obtained using two enzymes (phospholipase D and choline oxidase), both immobilised in kappa-Carrageenan gel and, as electrochemical transducer, an amperometric gas diffusion electrode for oxygen. The response of the b...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00212-x
更新日期：1998-12-01 00:00:00
abstract：:A simple and rapid method was developed for measuring 10 organophosphorus pesticides (acephate, methidathion, dichlorvos, fenthion, EPN, diazinon, phenthoate, malathion, fenitrothion, and cyanophos) in the serum of acute poisoning patients by LC/MS. Following deproteinization by acetonitrile, an aliquot of the biologi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.01.036
更新日期：2007-05-09 00:00:00
abstract：:Urea is an important indicator of liver and kidney disease, and very frequently determined in clinical chemistry. The reference measurement procedures (RMPs) for serum urea recognized by the Joint Committee for Traceability in Laboratory Medicine are spectrophotometry, and isotope dilution (ID)-mass spectrometry (MS) ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.09.023
更新日期：2019-01-05 00:00:00
abstract：:A simple isocratic reversed-phase HPLC method for the determination of gabapentin and its major degradation impurity, 3,3-pentamethylene-4-butyrolactam, was developed and validated for use in the analysis of pharmaceutical tablets and capsules. Separation was achieved on a Brownlee Spheri-5 Cyano column using an aceto...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2006.12.020
更新日期：2007-04-11 00:00:00
abstract：:In the framework of a preliminary investigation on the plasma profile of cloxacillin after oral administration, a simple and rapid LC method was developed for the direct determination of this compound in human plasma. The on-line sample clean-up was carried out using a weak anion exchanger (diethylaminoethyl groups) a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.09.017
更新日期：2005-01-04 00:00:00
abstract：:Surface plasmon resonance (SPR) is a promising tool in sensor technology for biomedical applications. An SPR based immunosensor was established for label free and real time assay for the serological diagnosis of dengue virus infection employing the dengue virus antigen as the sensing element. The dengue virus antigen ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.01.001
更新日期：2010-06-05 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：:Extemporaneous oral preparations are routinely compounded in the pharmacy due to a lack of suitable formulations for special populations. Such small-scale pharmacy preparations also present an avenue for individualized pharmacotherapy. Orodispersible films (ODF) have increasingly been evaluated as a suitable dosage fo...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.11.068
更新日期：2018-02-20 00:00:00
abstract：:Since culture-based methods are costly and time consuming, alternative methods are investigated for the quantification of probiotics in commercial products. In this work ATR- FTIR vibration spectroscopy was applied for the differentiation and quantification of live Lactobacillus (La 5) in mixed populations of live and...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.03.009
更新日期：2018-05-30 00:00:00
abstract：:The application of fully automated, unattended sample preparation performed by a laboratory robot for the analysis of drugs in biological samples requires the prevention of system failures which may arise in the on-line coupled chromatographic system or in other components of the robotic system. A computer program has...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(90)80083-2
更新日期：1990-01-01 00:00:00
abstract：:A first-derivative spectrophotometric method for the determination of irbesartan (IRB) alone and in the presence of hydrochlorothiazide (HCT) is described. Measurements are made at the zero-crossing wavelength at 263.0 nm for IRB. The calibration graph was linear over the range 1.0-12.0 mg l(-1) of IRB, detection limi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00073-0
更新日期：2002-06-20 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：:Retention factors were determined for a set of 26 drugs, for which brain/blood concentration data are available, using immobilised artificial membrane (IAM) chromatography. The compound set represented acidic, basic and neutral drugs from various structural classes. The relationship between IAM retention and lipophili...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/s0731-7085(96)01883-3
更新日期：1997-01-01 00:00:00
abstract：:Staphylococcus aureus, methicillin-resistant Staphylococcus aureus and Klebsiella pneumoniae are the most representative bacteria causing infectious diseases. Due to the increased application of antibiotics, the bacterial resistance is growing causing severe complications. Therefore, a sensitive determination of these...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.10.025
更新日期：2017-02-05 00:00:00
abstract：:1-Benzo[b]thien-2-ylethanone (2-acetylbenzothiophene, 2-ABT) and related impurities were determined using a reverse-phase high performance liquid chromatography system and UV detection at 254 nm. Separation was achieved isocratically on a 4.6 mm x 25 cm, 5 microns Zorbax Rx-C8 column using an eluent which is 0.2% perc...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(95)01650-3
更新日期：1996-02-01 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：:The alkaline hydrolysis of mitomycin C has been studied over a wide range of pH/H_(7-15). A stability-indicating high-performance liquid chromatographic (HPLC) method was used to separate the degradation products from the parent drug. The quantitative effects of temperature and buffers on the degradation of mitomycin ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(85)80007-8
更新日期：1985-01-01 00:00:00
abstract：:Isoflavones are suitable guest molecules for inclusion complex formation with cyclodextrins (CDs). The molecular encapsulation with CDs results in a solid, molecularly dispersed form and in a significantly improved aqueous solubility of isoflavones. Genistein, a key isoflavone constituent of Ononidis spinosae radix wa...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.06.007
更新日期：2008-11-04 00:00:00
abstract：:Highly selective non-covalent clenbuterol (CL) imprinted polymers were prepared using methacrylic acid as monomer and ethylene glycol dimethacrylate as cross-linking agent. HPLC experiments with columns packed with this material showed that CL are selectively recognised with respect to all other adrenergic substances ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(00)00477-5
更新日期：2001-05-01 00:00:00
abstract：:As one of the dietary flavonoids, kaempferol (KP) has been well known to show strong anti-oxidative effect along with other biological properties. However, the oral bioavailability of KP is relatively low due to its poor solubility. In this study, we intended to increase the solubility and bioavailability of KP by pre...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.05.017
更新日期：2015-10-10 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
abstract：:The development of biosensor technologies for the investigation of biomolecular interactions has markedly advanced over the last years. One promising biosensor platform, the Bio-Layer Interferometry (BLI), was developed by ForteBio with the main focus to qualify and quantify protein/protein interactions in research an...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.10.008
更新日期：2013-01-01 00:00:00
abstract：:Diltiazem (DTZ) is an optically active calcium channel blocker having a benzodiazepine structure. The drug used in therapy is (+)-cis-diltiazem with configuration (2S,3S). To describe the analytical profile of DTZ different stationary phases (RP-18, RP-8, monolithic support) were tested. The best separation of DTZ fro...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.11.050
更新日期：2005-04-01 00:00:00
abstract：:A sensitive, specific and rapid high performance liquid chromatography - tandem mass spectrometric (LC/MS/MS) method for the determination of cyclovirobuxine D in human plasma was developed and validated. The triple-quadrupole tandem mass spectrometric detector with an electrospray interface (ESI) was operated under t...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 临床试验,杂志文章
doi：10.1016/j.jpba.2006.04.025
更新日期：2006-10-11 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
