Chromatographic methods for determining the identity, strength and purity of ranitidine hydrochloride both in the drug substance and its dosage forms--an exercise in method selection, development, definition and validation.

Abstract:

:The selection, development, definition and validation of selective stability-indicating procedures for high-performance liquid chromatographic and thin-layer chromatographic analyses of ranitidine hydrochloride are described. The procedures used in conjunction can be applied to the quality assurance and stability assessments of both the drug substance and its dosage forms and serve to establish the identity, strength and purity of this drug used in the treatment of peptic ulcer and related conditions.

journal_name

J Pharm Biomed Anal

authors

Evans MB,Haywood PA,Johnson D,Martin-Smith M,Munro G,Wahlich JC

doi

10.1016/0731-7085(89)80062-7

subject

Has Abstract

pub_date

1989-01-01 00:00:00

pages

1-22

issue

1

eissn

0731-7085

issn

1873-264X

pii

0731-7085(89)80062-7

journal_volume

7

pub_type

杂志文章,评审
  • Use of slurry suspension sample introduction technique in fast multielement analysis of multimineral and multivitamin formulations by inductively coupled plasma atomic emission spectrometry.

    abstract::A slurry suspension sampling technique has been developed and optimized for rapid multielemental analysis of multivitamin/multimineral preparations using inductively coupled plasma atomic emission spectrometry (ICP-AES). The following macro-, micro- and trace-elements: Ca, Mg, Mn, Fe, Cr, Al, Ag, B, Ba, Bi, Cd, Co, Cu...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2008.02.010

    authors: Zachariadis GA,Olympiou AF

    更新日期:2008-07-15 00:00:00

  • Simultaneous stereoselective analysis of venlafaxine and O-desmethylvenlafaxine enantiomers in clinical samples by capillary electrophoresis using charged cyclodextrins.

    abstract::Capillary electrophoresis (CE) was used for the simultaneous chiral determination of venlafaxine (Vx), a new antidepressant drug and its main active metabolite. O-desmethyl venlafaxine (ODV). Among the charged cyclodextrins (CD) tested, phosphated gamma-CD was the most appropriate. Resolution of Vx and ODV was obtaine...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(00)00280-6

    authors: Rudaz S,Stella C,Balant-Gorgia AE,Fanali S,Veuthey JL

    更新日期:2000-08-01 00:00:00

  • Direct quantitation of free, encapsulated, total doxorubicin and doxorubicinol in stabilized frozen human plasma to support a BE study of liposomal doxorubicin.

    abstract::Regulatory guidance requires the quantification of encapsulated and free doxorubicin for a liposomal doxorubicin injection bioequivalence study. Due to the instability of liposome formulations in plasma samples, the release of free drug from the liposomal encapsulated doxorubicin during sample handling would result in...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113388

    authors: Ji Y,Zhang X,Liu J,Chen Y,Meng M,Li C,Wang L

    更新日期:2020-09-10 00:00:00

  • Validation of a simple HPLC-UV method for rifampicin determination in plasma: Application to the study of rifampicin arteriovenous concentration gradient.

    abstract::In clinical practice, rifampicin exposure is estimated from its concentration in venous blood samples. In this study, we hypothesized that differences in rifampicin concentration may exist between arterial and venous plasma. An HPLC-UV method for determining rifampicin concentration in plasma using rifapentine as an i...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2016.02.013

    authors: Goutal S,Auvity S,Legrand T,Hauquier F,Cisternino S,Chapy H,Saba W,Tournier N

    更新日期:2016-05-10 00:00:00

  • A stability-indicating method for the determination of melphalan and related impurity content by gradient HPLC.

    abstract::A robust gradient high performance liquid chromatographic (HPLC) procedure is described for the simultaneous determination of melphalan content and related impurities in melphalan drug substance. The sample solution is prepared in methanol and injected. A linear gradient from 5 to 60% acetonitrile in water containing ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(99)00011-4

    authors: Brightman K,Finlay G,Jarvis I,Knowlton T,Manktelow CT

    更新日期:1999-07-01 00:00:00

  • A new HPLC micromethod to measure total plasma homocysteine in newborn.

    abstract::Total plasma homocysteine (tHcy) in children may be an useful biochemical marker for genetic risk of premature cardiovascular disease. We reported a rapid, isocratic HPLC method able to process very small amount of newborn plasma samples. A blood sample from heel capillary circulation was collected, using a heparinize...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(00)00573-2

    authors: Bartesaghi S,Accinni R,De Leo G,Cursano CF,Campolo J,Galluzzo C,Vegezzi PG,Parodi O

    更新日期:2001-03-01 00:00:00

  • Cell-based assays in combination with ultra-high performance liquid chromatography-quadrupole time of flight tandem mass spectrometry for screening bioactive capilliposide C metabolites generated by rat intestinal microflora.

    abstract::Many plant-derived glycosides are used as medications. It is common that these glycosides show poor intestinal absorption but their metabolites generated by intestinal microflora demonstrate strong bioactivity. Hence, it is crucial to develop a method for the identification and characterization of the metabolites, and...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2015.11.029

    authors: Cheng Z,Huang M,Chen G,Yang G,Zhou X,Chen C,Zhang Y,Xu Y,Feng Y,Zhang L,Jiang H

    更新日期:2016-02-05 00:00:00

  • Microbiological assay for azithromycin in pharmaceutical formulations.

    abstract::The validation of a microbiological assay, applying the cylinder-plate method, for the determination of the antibiotic azithromycin is described. Using a strain of Micrococcus luteus ATCC 9341 as the test organism, azithromycin at concentrations ranging from 0.1 to 0.4 microgml(-1) could be measured in capsules and su...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(02)00213-3

    authors: Breier AR,Garcia CV,Oppe TP,Steppe M,Schapoval EE

    更新日期:2002-07-31 00:00:00

  • Daptomycin-modified magnetic beads integrated with lysostaphin for selective analysis of Staphylococcus.

    abstract::An antibiotic-affinity method was developed for analyzing Staphylococcus on the basis of the strong binding capability of daptomycin towards Gram-positive bacteria cellular membrane, as well as the selective lytic action of lysostaphin towards Staphylococcus. Daptomycin-modified magnetic beads were adopted to enrich S...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2019.112785

    authors: Wang M,Fan E,Wu Y,Fu Z

    更新日期:2019-10-25 00:00:00

  • Rapid authentication and differentiation of herbal medicine using 1H NMR fingerprints coupled with chemometrics.

    abstract::The public concern and increasing awareness of herbal medicines calls for methods available to assure quality and authenticity. In the present study, a novel strategy combing 1H nuclear magnetic resonance (1H NMR) spectral analyses coupled with chemometrics was developed and validated to allow comprehensive analysis a...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2018.08.003

    authors: Sun L,Wang M,Ren X,Jiang M,Deng Y

    更新日期:2018-10-25 00:00:00

  • Analysis of beta-lactam antibiotics by high performance liquid chromatography-atmospheric pressure chemical ionization mass spectrometry using bromoform.

    abstract::The novel identification method for a heat-unstable antibiotic, FC/TA-891 and its active metabolite (FCE22101) by high-performance liquid chromatography (HPLC)-atmospheric pressure chemical ionization mass spectrometry (APCI-MS) employing bromoform as an ionization acceleration solvent, was applied to eight penicillin...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(02)00402-8

    authors: Horimoto S,Mayumi T,Aoe K,Nishimura N,Sato T

    更新日期:2002-11-07 00:00:00

  • Electrochemical detection of enzyme labeled DNA based on disposable pencil graphite electrode.

    abstract::Electrochemical biosensor for the detection of DNA hybridization using the reduction signal of alpha-naphthol is described. A pencil graphite electrode was used as a working electrode. Capture probes were covalently attached on to the pencil graphite electrode surface (PGE) at the 5' end amino group by using N-(dimeth...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2004.12.011

    authors: Kara P,Erdem A,Girousi S,Ozsoz M

    更新日期:2005-06-01 00:00:00

  • An enzyme immunoassay to determine the levels of specific antibodies toward bacterial surface antigens in human immunoglobulin preparations and blood serum.

    abstract::Human polyvalent intravenous immunoglobulin (IVIG) preparations are used as a complementary aid to the proper antimicrobial treatment of severely septic patients in intensive care units (ICUs) and/or as a prophylactic agent to immunocompromised hosts, particularly prone to bacterial infections. There is skepticism abo...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(99)00087-4

    authors: Lamari F,Anastassiou ED,Tsegenidis T,Dimitracopoulos G,Karamanos NK

    更新日期:1999-09-01 00:00:00

  • Characterization of the preferred orientation of delta-mannitol crystallites in tablets.

    abstract::The crystallographic texture, i.e. the preferred orientation of crystallites of delta-mannitol samples, has been experimentally determined by pole figure analysis. The pole figures were measured with an X-ray diffraction texture goniometer. It was found that already the uncompressed delta-mannitol powder sample was sl...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2004.07.019

    authors: Koivisto M,Virjonen T,Heikkilä T,Lehto VP

    更新日期:2004-11-15 00:00:00

  • Identification, isolation and characterization of dolutegravir forced degradation products and their cytotoxicity potential.

    abstract::Dolutegravir was approved by USFDA, Canada and European regulatory authorities as antiretroviral medication. In this article, DLG forced degradation studies as per the International Council for Harmonization (ICH) prescribed stress conditions was conducted and the resulting degradants were fully characterized. DLG was...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2019.06.022

    authors: Saida SJ,Manikandan A,Kaliyaperumal M,Rumalla CS,Khan AA,Jayaraman VB,Yanaka R,Venkat Rao S

    更新日期:2019-09-10 00:00:00

  • Determination of aucubin by supramolecular solvent-based dispersive liquid-liquid microextraction and UPLC-MS/MS: Application to a pharmacokinetic study in rats with type 1 diabetes.

    abstract::A novel method was developed for the determination of aucubin in rat serum by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) with supramolecular solvent (SUPRAS)-based dispersive liquid-liquid microextraction (DLLME). The SUPRAS was prepared with pentanol as extraction solvent and tetrah...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113301

    authors: Lian X,Wang N,Ma L,Jiang H,Bai D,Xue H,Ma Q

    更新日期:2020-07-15 00:00:00

  • Determination of DPPH free radical scavenging activity by reversed-phase HPLC: a sensitive screening method for polyherbal formulations.

    abstract::The colorimetric method of evaluation of antioxidant activity by scavenging 1,1-diphenyl-2-picrylhydrazyl (DPPH) free radical is with certain shortcomings like failure to indicate antioxidant activity of certain drugs and interference from color pigments of natural products. A specific HPLC method was developed for ev...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2005.07.042

    authors: Chandrasekar D,Madhusudhana K,Ramakrishna S,Diwan PV

    更新日期:2006-02-13 00:00:00

  • Development of a chiral assay for a novel, nonfluorinated quinolone, PGE-9509924, in dog plasma using high performance liquid chromatography with electrospray tandem mass spectrometry or fluorescence detection.

    abstract::PGE-9509924 is a nonfluorinated quinolone and is active against a variety of susceptible and drug resistant bacteria in vitro and in animal infection models. A method for determining both enantiomers of PGE-9509924 in dog plasma has been developed. The enantiomers are derivatized with a chiral derivatizing agent, (-)-...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(01)00717-8

    authors: Zoutendam PH,Canty JF,Martin MJ,Dirr MK

    更新日期:2002-08-22 00:00:00

  • Difference spectrophotometric assay of 5-hydroxymethylfurfuraldehyde in hydrolysed pharmaceutical syrups-II. Isoniazid reagent.

    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

    authors: Davidson AG,Dawodu TO

    更新日期:1988-01-01 00:00:00

  • Solid phase adsorption of emodin on hydrotalcites and inorganic oxides: A preliminary study.

    abstract::Solid phase extraction applied to plant matrices is nowadays a well validated technique allowing the concentration and purification of selected secondary metabolites for subsequent analysis. In this short communication we screened the efficiency of 16 selected solid supports including layered structures (hydrotalcites...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113348

    authors: Genovese S,Epifano F,Palumbo L,Pulito G,Bastianini M,Cardellini F,Spogli R,Fiorito S

    更新日期:2020-08-05 00:00:00

  • Application of HPLC and HPTLC for the simultaneous determination of tizanidine and rofecoxib in pharmaceutical dosage form.

    abstract::Two methods are described for the simultaneous determination of tizanidine and rofecoxib in binary mixture. The first method was based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 311 nm. The separation was carried out on Merck HPTLC aluminium sheets of silica gel 60 F2...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2004.09.036

    authors: Kaul N,Dhaneshwar SR,Agrawal H,Kakad A,Patil B

    更新日期:2005-02-07 00:00:00

  • Quantification of natural products in herbal supplements: A combined NMR approach applied on goldenseal.

    abstract::Authentication of natural products is of major relevance in the context of manufactured drugs or herbal supplements since such active products generate a lucrative market. The analytical method to identify and quantify valuable natural products is critical for quality control and product assignment of herbal supplemen...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2018.11.062

    authors: Le PM,Milande C,Martineau E,Giraudeau P,Farjon J

    更新日期:2019-02-20 00:00:00

  • Improved bioautographic assay on TLC layers for qualitative and quantitative estimation of xanthine oxidase inhibitors and superoxide scavengers.

    abstract::A new agar-free bioautographic assay for xanthine oxidase (XO) inhibitors and superoxide scavengers on TLC layers was developed and validated. Compared to the first version of TLC bioautographic agar overlay method, our bioautographic assay greatly improved the sensitivity and quantification ability. The limit of dete...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2017.11.077

    authors: Kong Y,Li X,Zhang N,Miao Y,Feng H,Wu T,Cheng Z

    更新日期:2018-02-20 00:00:00

  • Characterization of the acidic species of a monoclonal antibody using free flow electrophoresis fractionation and mass spectrometry.

    abstract::Antibody charge heterogeneity is one of the major product-related variants in recombinant biopharmaceuticals, which has been commonly monitored by imaged capillary isoelectric focusing (icIEF). Due to the challenges with sample recovery and fractionation, other charge-based analytical approaches have been explored as ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113217

    authors: Liu S,Madren S,Feng P,Sosic Z

    更新日期:2020-06-05 00:00:00

  • Analysis by liquid chromatography and infrared spectrometry of di(2-ethylhexyl)phthalate released by multilayer infusion tubing.

    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

    authors: Bourdeaux D,Sautou-Miranda V,Bagel-Boithias S,Boyer A,Chopineau J

    更新日期:2004-04-01 00:00:00

  • Metabonomic identification of the effects of the Zhimu-Baihe saponins on a chronic unpredictable mild stress-induced rat model of depression.

    abstract::The herbal pair Zhimu-Baihe (Zhimu: Anemarrhena asphodeloides; Baihe: Lilium brownii var. viridulum) is a traditional Chinese medicament used for the treatment of depression. However, the relevant mechanisms of action has not been clarified. This study investigated the anti-depressant activity of the total saponins fr...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2016.06.019

    authors: Du H,Wang K,Su L,Zhao H,Gao S,Lin Q,Ma X,Zhu B,Dong X,Lou Z

    更新日期:2016-09-05 00:00:00

  • Development and validation of a LC-MS quantification method for the lantibiotic MU1140 in rat plasma.

    abstract::This study reports the first ever development and validation of a quantification method for a lantibiotic in plasma. This method was developed for the quantification of total MU1140 in Sprague Dawley rat plasma. The procedure involved acidification of plasma samples with formic acid followed by precipitation of plasma...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2008.12.022

    authors: Ghobrial OG,Derendorf H,Hillman JD

    更新日期:2009-05-01 00:00:00

  • An HPLC chromatographic reactor approach for investigating the hydrolytic stability of a pharmaceutical compound.

    abstract::The solution-phase hydrolysis kinetics of the Aprepitant (Emend) prodrug, Fosaprepitant Dimeglumine, were investigated using an HPLC chromatographic reactor approach. The term 'chromatographic reactor' refers to the use of an analytical-scale column as both a flow-through reactor and, simultaneously, as separation med...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2006.02.005

    authors: Skrdla PJ,Abrahim A,Wu Y

    更新日期:2006-06-07 00:00:00

  • Determination of zabofloxacin in rat plasma by liquid chromatography with mass spectrometry and its application to pharmacokinetic study.

    abstract::The objective of the present study was to develop a rapid and sensitive method for the determination of zabofloxacin, a novel, broad-spectrum fluoroquinolone antibiotic, in rat plasma. Rat plasma samples were deproteinized with methanol, and then were injected into an LC-MS system for quantification. Zabofloxacin and ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2010.11.001

    authors: Jin HE,Lee KR,Kang IH,Chung SJ,Shim CK

    更新日期:2011-03-25 00:00:00

  • A sensitive liquid chromatography-mass spectrometry method for simultaneous determination of three diterpenoid esters from Euphorbia lathyris L. in rat plasma.

    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

    authors: Meng X,Zhao X,Long Z,Yuan Y,Zhuang H,Bi K,Chen X

    更新日期:2013-01-01 00:00:00