Abstract：
:A fast static headspace gas chromatography (HS-GC) method was developed to separate all residual solvents present in commercial active pharmaceutical ingredient (API) batches of permethrin. A total of six residual solvents namely 2-methylpentane, 3-methylpentane, methylcyclopentane, n-hexane, cyclohexane and toluene were found in typical commercial batches of permethrin; and three of them are not in the list of ICH solvents. All six residual solvents were baseline separated in five minutes by the new method presented in this paper. The method was successfully validated as per International Conference on Harmonisation (ICH) guidelines. Evaluation of this method was conducted to separate 26 commonly used solvents in the manufacturing of various APIs, key intermediates of APIs and pharmaceutical excipients. The results of the evaluation demonstrated that this method can also be used as a general method to determine residual solvents in various APIs, intermediates and excipients that are used in pharmaceutical products.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Tian J,Rustum Adoi
10.1016/j.jpba.2016.06.020subject
Has Abstractpub_date
2016-09-05 00:00:00pages
408-415eissn
0731-7085issn
1873-264Xpii
S0731-7085(16)30337-5journal_volume
128pub_type
杂志文章abstract：:Miniaturization of analytical procedures through microchips, lab-on-a-chip or micro total analysis systems is one of the most recent trends in chemical and biological analysis. These systems are designed to perform all the steps in an analytical procedure, with the advantages of low sample and reagent consumption, fas...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2013.07.008
更新日期：2014-01-01 00:00:00
abstract：:A liquid chromatographic tandem mass spectrometric method for the quantitative determination of sumatriptan base in human plasma and urine has been developed and validated over the concentration range 0.2-20 ng base ml-1. Sumatriptan is a 5-HT1 receptor agonist which has found widespread use in the treatment of migrai...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(97)00220-3
更新日期：1998-07-01 00:00:00
abstract：:Gamma-hydroxybutyric acid (GHB) and its "pro-drugs", gamma-butyrolactone (GBL) and 1,4 butanediol (1,4-BD), are drugs of abuse with depressant effects on the central nervous system. Many analytical methods have been proposed for the quantitative determination of these compounds mainly in biological matrices but only f...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.10.006
更新日期：2013-02-23 00:00:00
abstract：:Alzheimer's disease (AD) is a neurodegenerative disease that seriously affects daily life. Schisandra chinensis (Turcz.) Baill. Fructus (SCF) and Alpinia oxyphylla Miq. Fructus (AOF) have been regarded as classical herbs for dementia since ancient times. Alpinia oxyphylla Miq.-Schisandra chinensis (Turcz.) Baill. herb...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.112874
更新日期：2020-01-05 00:00:00
abstract：:An analytical GC-MS method based on nonpolar fused silica capillary column was developed to analyze the lipophilic constituents, mainly alkamides, from the root extracts of Echinacea purpurea (L.) Moench. In particular, the proposed method was applied to evaluate the phytochemical impacts of cucumber mosaic cucumoviru...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00146-2
更新日期：2002-08-01 00:00:00
abstract：:This study aimed to reveal chemical profiles and biological activities of ethyl acetate (EA), methanol (MeOH), and water extracts of Lotus corniculatus. Ethnobotanical reports have indicated the importance of phytochemical properties of the genus Lotus. In this study, the effects of medicinal plant extracts on antioxi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.05.068
更新日期：2019-09-10 00:00:00
abstract：:A simple and rapid method for the determination of partition constants in the n-octanol/water system is presented. The substance under study is dissolved in n-octanol or water, and injected into a stream of the corresponding phase. Liquid-liquid segmented flow is utilized for equilibration of the two phases and after ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(94)00107-3
更新日期：1994-12-01 00:00:00
abstract：:Standard-size (4 mm ID) and micro-HPLC columns (0.5 mm ID) packed with a quinine-based ion-exchange type chiral stationary phase are comparatively evaluated for the separation of peptide enantiomers with up to six amino acid residues. The results show that downscaling the separation system in order to gain the advanta...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00521-6
更新日期：2003-01-15 00:00:00
abstract：:Recombinant DNA technology has made possible the large-scale production of proteins for pharmaceutical applications. As a result, there has been a renaissance in methodology which can provide information on the structural stability and character of these materials. Circular dichroism (CD) spectroscopy, with its sensit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/0731-7085(89)80049-4
更新日期：1989-01-01 00:00:00
abstract：:This review paper discusses the success of columns packed with superficially porous particles (SPP) in liquid chromatography for the analysis of peptides and proteins. First, it summarizes the history of SPP, including the development of different SPP generations from particles of 50 μm to sub-2 μm. It also critically...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2018.06.006
更新日期：2018-09-05 00:00:00
abstract：:Simple and express coulometric method for the evaluation of the total antioxidant capacity (TAC) of human plasma based on the reaction with electrogenerated bromine is applied. TAC of plasma from patients with different ethiology of chronic renal failure was observed. The levels of antioxidant capacity for venous and ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 临床试验,杂志文章
doi：10.1016/j.jpba.2005.08.017
更新日期：2006-03-03 00:00:00
abstract：:CRx-102 is an oral synergistic combination drug which contains the cardiovascular agent, dipyridamole (DP) and a very low dose of the glucocorticoid, prednisolone (PRED). CRx-102 works through a novel mechanism of action in which DP selectively amplifies the anti-inflammatory activity of PRED without replicating its s...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.04.013
更新日期：2009-09-08 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：:To separate proteins solely based on their difference in hydrodynamic volume in size exclusion chromatography (SEC), the ionic strength of the mobile phase has to be increased in order to avoid secondary ionic interactions between proteins and the stationary phase. However, adding salts to the mobile phase can have a ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.09.031
更新日期：2017-09-10 00:00:00
abstract：:A non-aqueous capillary electrophoresis method for the determination of oxytetracycline in an ointment have been validated. The oxytetracycline (OTC) is separated from related impurities and degradation products as metal chelates with magnesium ions. Thus, the method show high selectivity. The sample preparation is pe...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(96)01998-x
更新日期：1997-05-01 00:00:00
abstract：:Near-infrared (NIR) spectroscopy is one of the most successful pharmaceutical process analytical tools. For botanical drug products (BDPs), many studies have applied NIR spectroscopy for rapid analysis of botanical raw materials, extracts and formulations. However, the real-time process analysis reported for BDPs was ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.06.046
更新日期：2019-09-10 00:00:00
abstract：:An integrated strategy based on characteristic fragment filter (CFF) supplemented by multivariate statistical analysis (MSA) for MSn chromatograms [(CFF)s MSA] was proposed for the large-scale detection of natural plant-derived ingredients in vivo. To prove the practicability of this [(CFF)s MSA] strategy, rhubarb was...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.05.049
更新日期：2019-09-10 00:00:00
abstract：:A selective method for the determination of sulphobutylether-beta-cyclodextrin (SBECD) in human plasma has been developed and validated over the range 4-200 microg ml(-1). SBECD is extracted from plasma using end-capped cyclohexyl solid phase extraction cartridges. This is followed by high performance size exclusion c...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00283-6
更新日期：2000-06-01 00:00:00
abstract：:Hydrates are of great pharmaceutical relevance and even though they have been characterized thoroughly by various analytical techniques, there is barely literature available on molecular mobility of the hydrate water studied by NMR relaxation in the time domain. The aim of this work was to examine the possibility of d...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.01.017
更新日期：2017-04-15 00:00:00
abstract：:As a part of our investigations on the content and stability of herbal drug preparations, we evaluated the content and stability of tinctures and mother tinctures of Hawthorn leaves and flowers and Hawkweed. Hawthorn preparations are mainly used by patients with cardiac diseases; Hawkweed is employed for the treatment...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.01.046
更新日期：2007-05-09 00:00:00
abstract：:Archived dried blood spots (DBS) following newborn screening are an attractive resource for interrogating early-life biology using untargeted metabolomics. Therefore, they have the potential to substantially aid etiological studies, particularly for rare and low-frequency childhood diseases and disorders. However, met...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113574
更新日期：2020-11-30 00:00:00
abstract：:Two HPLC systems have been developed for the investigation of flumecinol (3-trifluoromethyl-alpha-ethyl-benzhydrol). The reversed-phase system (LiChrosorb RP-18; methanol-water, 7:3, v/v) enables the isolation and identification of the impurities. The chiral system (Chiralcel OD; hexane-2-propanol, 98:2, v/v) separate...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(91)80088-q
更新日期：1992-10-01 00:00:00
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：:Protonation and equilibrium constant for oxytetracycline (OTC) and doxycycline (DOX) with Zn2+, Ca2+ and Mg2+ ions have been determined with Calvin-type pH-metric titrations under physiological conditions (37 degrees C, 0.15 M NaCl ionic strength). Even though OTC and DOX are similar in structure, major differences we...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(96)01734-7
更新日期：1996-06-01 00:00:00
abstract：:A gradient high-performance liquid chromatographic (HPLC) method was developed for the analysis of Synercid freeze-dried powder in routine quality control, stability and compatibility studies. This method is suited for a simultaneous assay of drug substances and impurities. The method was validated for precision, repr...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00242-8
更新日期：1999-04-01 00:00:00
abstract：:NMR spectra of urine from rats treated with a range of liver, kidney and testicular toxins at various doses were measured and classified using neural network methods. Toxin-induced changes in the levels of 18 low molecular weight endogenous urinary metabolites were assessed using a simple semi-quantitative scoring sys...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(95)01278-s
更新日期：1995-03-01 00:00:00
abstract：:A simple and sensitive high-performance liquid chromatographic method for the determination of piperacillin in plasma is described. A C8 reversed-phase column was used with a mobile phase consisting of methanol-water-triethylamine (550:450:4, v/v/v) adjusted to pH = 3 with orthophosphoric acid and UV detection at 270 ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(91)80142-v
更新日期：1991-01-01 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 rapid difference spectrophotometric assay of 5-hydroxymethylfurfuraldehyde (5-HMF) in certain degraded syrups is described. The method involves the measurement of the difference absorbance at 340 nm of the isonicotinoyl hydrazone of 5-HMF, formed at room temperature in an acidic solution of isoniazid, relative to an...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(88)80030-x
更新日期：1988-01-01 00:00:00
abstract：:Medroxyprogesterone acetate (MPA) injectable products are a key commodity for reproductive health and are available in the global market from a variety of manufacturing sources. Depending on the climatic zone conditions of the destination country for product use, MPA injectables are at risk of exposure to adverse tran...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113352
更新日期：2020-08-05 00:00:00
