Abstract：
:A study was conducted to investigate the quality of reference substances which were produced long before the introduction of advanced analysis and purification techniques. The quality and antimicrobial activity of WHO and EP oxytetracycline, doxycycline, colistin and spiramycin reference standards were assessed. The oldest substance was stored for 54 years in a freezer. Assay and purity tests were conducted according to Ph. Eur. 6.0. Additionally, antibacterial activity was tested with the microbiological method according to Ph. Eur. 4.0 (agar diffusion method). The results of the study show that several of the tested substances remained stable for over 40 years and one for over 50 years of storage. In most cases, the determined potency is close to the declared one, regardless of the method used (HPLC or microbiological). Composition analysis of multi-substance antibiotics (colistin and spiramycin) showed important differences compared with new reference substances. Results also indicate that no excessive degradation occurred during the entire storage period and impurity levels have not changed significantly.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
German R,Bukowska B,Pajchel G,Grzybowska W,Tyski Sdoi
10.1016/j.jpba.2009.09.031subject
Has Abstractpub_date
2010-02-05 00:00:00pages
758-63issue
3eissn
0731-7085issn
1873-264Xpii
S0731-7085(09)00596-2journal_volume
51pub_type
杂志文章abstract：:An automated solid-phase extraction workstation was used to develop, characterize and validate two separate HPLC methods for quantifying drugs in plasma. Method development was facilitated by workstation functions which allowed wash solvents of varying organic composition to be mixed and tested automatically. The prec...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(97)00278-1
更新日期：1998-08-01 00:00:00
abstract：:The goal of this study was the methodological development of Raman microscopy application for advanced and reliable monitoring of pharmaceutical tablets disintegration in aqueous media. First step of the development involved new design and testing of static, flow cell and tablet holders. On-line Raman mapping method e...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.02.019
更新日期：2019-05-10 00:00:00
abstract：:A sensitive, selective and rapid liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-MS/MS) method has been developed for the quantification of the novel transforming growth factor-β (TGF-β) inhibitor SB-505124 in rat plasma and then validated. Plasma samples were prepared by simple protein prec...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.09.002
更新日期：2016-01-05 00:00:00
abstract：:We have developed a simple and rapid time-resolved fluoroimmunoassay (TR-FIA) for simultaneous determination of alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG) and estriol (E3) using europium and samarium ion chelate. In the proposed method, we used a combination of a 96-well microtiter plate for the AFP a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00010-2
更新日期：1999-06-01 00:00:00
abstract：:The extensive analytical characterization of protein biotherapeutics, especially of biosimilars, is a critical part of the product development and registration. High-resolution mass spectrometry became the primary analytical tool used for the structural characterization of biotherapeutics. Its high instrumental sensit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2018.08.024
更新日期：2018-11-30 00:00:00
abstract：:Remifentanil (GI87084) is a phenylaminopiperidine derivative of the fentanyl type with a potent analgesic activity and ultra-short half-life. The N-substituted labile methyl propanoate ester group is highly susceptible to cleavage by endogenous esterases and by chemical hydrolysis. The hydrolysis is stopped by additio...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(94)90035-3
更新日期：1994-02-01 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 simple high-performance liquid chromatographic assay with using UV detection (266 nm) was developed to determine a novel gastroprokinetic agent, Z-338 in dog plasma. The extraction procedure using solid-phase extraction with a Isolute SCX column produces extremely clean eluates and a high recovery. Intra- and inter-...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(00)00593-8
更新日期：2001-06-01 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 traditional Chinese medicine 'Qing Kai Ling' injection after deterioration is distinguished from the original formulation using Fourier-transform infrared spectroscopy (FTIR) and two-dimensional correlation infrared spectroscopy (2D-IR). The IR spectra of the injections before and after deterioration are so simila...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00485-5
更新日期：2003-01-01 00:00:00
abstract：:Banxia Xiexin decoction (BXD) is an effective Chinese Medicinal Prescription in treating gastroenteritis diseases. In this study an ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed to separate and determine 18 major active ingredients of BXD in order to guarantee ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.10.002
更新日期：2014-01-01 00:00:00
abstract：:Amlodipine is a long acting dihydropyridine calcium antagonist recently introduced for the treatment of angina and hypertension. In order to document its stability in vitro and to develop a pharmacokinetic model in rabbits, a new reversed-phase liquid chromatography (LC) assay with UV detection was developed. The meth...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(91)80178-c
更新日期：1991-01-01 00:00:00
abstract：:The Mahuang-Xingren herb-pair (MX), the combination of Herba Ephedrae (Mahuang in Chinese) and Semen Armeniacae Amarum (Xingren in Chinese), is a classical combination used in traditional Chinese Medicine to treat asthma and bronchitis. A simple and reliable ultra-performance liquid chromatography-tandem mass spectrom...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.02.004
更新日期：2015-05-10 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：:The development of high performance liquid chromatography method on amylose-based stationary phases (Chiralpak AD) has permitted to achieve the preparative enantioseparation of one benzimidazole derivative, potent-AMP-kinase (AMPK) activator with satisfactory yields. Analytical enantioseparation method was optimized a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.01.048
更新日期：2008-04-14 00:00:00
abstract：:Quantitative whole-body autoradiography (QWBA) and liquid scintillation counting (LSC) have been conducted to determine the metabolic profiles and tissue distribution of [(14)C] labeled artesunate (AS) injection in rats. The QWBA technique showed more accurate results in the quantification of radioactivity in 40 organ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.07.015
更新日期：2008-11-04 00:00:00
abstract：:Di(2-ethylhexyl)phthalate (DEHP), a plasticiser present in infusion equipment, is known to be harmful to human health. Various studies have shown that DEHP is released into drug solutions from polyvinyl chloride (PVC) infusion lines. New multi-layer tubing has therefore been marketed to overcome this problem. We asses...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2003.12.018
更新日期：2004-04-01 00:00:00
abstract：:Ziv-aflibercept (ziv-AFL) is a complex fusion protein which is widely used in hospitals for the treatment of colorectal metastatic cancer. Charge variants are critical attributes for assessing post-transitional modifications (PMTs) that have to be controlled during the development and manufacture of these proteins and...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113233
更新日期：2020-06-05 00:00:00
abstract：:The star plot (SP) is a method of displaying multivariate data. It can be used to display data with more than two variables. Combined with principal component analysis (PCA), more than two PCs can be displayed in one plane. Different variants of this method are applied to an atomic absorption spectrometry (AAS) data s...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00066-1
更新日期：1998-09-01 00:00:00
abstract：:In this article the merits of current liquid chromatography (LC) columns and techniques are reviewed, to include the following topics: (1) a brief introduction to rational therapeutic drug monitoring (TDM) to justify drug measurements; (2) selected recent survey results from the College of American Pathologists (CAP) ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/0731-7085(89)80041-x
更新日期：1989-01-01 00:00:00
abstract：:In recent years, dietary supplements and herbal medicines are increasing in popularity all over the world. However, it is problematic that some manufacturers illegally included synthetic drugs in their products. Due to the extremely complex matrices of those products, most existing methods for screening illegal adulte...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.07.035
更新日期：2006-02-13 00:00:00
abstract：:We analyzed some glycosaminoglycans and natural and artificial acidic polysaccharides using microchip electrophoresis in the buffer containing ethidium bromide, and found that they were successfully separated and detected within 150 s with comparable sensitivity with that of conventional electrophoresis using cellulos...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.11.024
更新日期：2005-03-09 00:00:00
abstract：:Adenosine deaminase (ADA), which is a key enzyme in the metabolism of purine nucleosides, plays important roles in diverse disorders, such as tuberculosis, diabetes, liver disorders, and cancer. Determination of the activities of ADA and its isoenzymes in body fluids has received considerable attention in the diagnosi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.02.045
更新日期：2018-05-10 00:00:00
abstract：:The aim of the present work was to develop a method for predicting the phase behaviour of four component systems consisting of oil, water and two surfactants from a limited number of screening experiments. Investigations were conducted to asses the potential of artificial neural networks (ANNs) with back-propagation t...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00232-5
更新日期：1999-03-01 00:00:00
abstract：:The aim of this work was to obtain the direct optical resolution of a new glutamate receptor antagonist ((p-chloro)1-aryl-6,7,-dimethoxy-1,2,3,4-tetrahydroisoquinoline, PS3), by liquid chromatography on Chiralcel OD column. A response surface methodology (RSM) was employed to optimize the enantiomeric separation of th...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2006.05.023
更新日期：2006-11-16 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：:A liquid chromatography tandem mass spectrometry method (LC-MS/MS) was developed to determine simultaneously the bioactive proteins including pertussis toxin (PT) subunits, filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae (FIM) in diphtheria, tetanus and acellular pertussis combined vaccine (DTaP). The tr...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.02.029
更新日期：2019-05-30 00:00:00
abstract：:Recently it was found that normal adults excrete pipecolic acid primarily as the D-enantiomer even though it is present in the blood stream mainly as the L-enantiomer (i.e. > 98% L). This study of pipecolic acid stereochemistry was extended to subjects with peroxisomal deficiencies since they are known to have high le...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(93)80044-2
更新日期：1993-10-01 00:00:00
abstract：:A reliable, convenient, and sensitive on-line sweeping-MEKC sample concentration technique has been applied for the simultaneous separation of six steroids including two pairs of epimer with 10mM phosphate buffer (pH 7.0) that contains 80mM sodium dodecyl sulfate (SDS), 14mM β-cyclodextrin (β-CD), and 4% (v/v) methano...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.07.024
更新日期：2011-12-05 00:00:00
abstract：:Microcolumn techniques involving pre-column concentration and post-column derivatization make good use of micro-scale high-performance liquid chromatography. The efficient use of microcolumns is illustrated by some applications to the analysis of amino acids, bile acids and catecholamines. The potential of new detecto...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(84)80073-4
更新日期：1984-01-01 00:00:00
