Forced degradation and impurity profiling: recent trends in analytical perspectives.

Abstract:

:This review describes an epigrammatic impression of the recent trends in analytical perspectives of degradation and impurities profiling of pharmaceuticals including active pharmaceutical ingredient (API) as well as drug products during 2008-2012. These recent trends in forced degradation and impurity profiling were discussed on the head of year of publication; columns, matrix (API and dosage forms) and type of elution in chromatography (isocratic and gradient); therapeutic categories of the drug which were used for analysis. It focuses distinctly on comprehensive update of various analytical methods including hyphenated techniques for the identification and quantification of thresholds of impurities and degradants in different pharmaceutical matrices.

journal_name

J Pharm Biomed Anal

authors

Jain D,Basniwal PK

doi

10.1016/j.jpba.2013.07.013

subject

Has Abstract

pub_date

2013-12-01 00:00:00

pages

11-35

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(13)00309-9

journal_volume

86

pub_type

杂志文章,评审
  • Investigation of transport of genistein, daidzein and their inclusion complexes prepared with different cyclodextrins on Caco-2 cell line.

    abstract::Isoflavonoids are widespread constituents in medical plants especially in legumes (Fabaceae), but occur in other different plant families as well (Rosaceae, Iridaceae, Amaranthaceae). Their antioxidant, estrogen-like, anti-inflammatory and analgesic effects make them promising compounds in therapy of important disorde...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2013.05.012

    authors: Daruházi AE,Kiss T,Vecsernyés M,Szente L,Szőke E,Lemberkovics E

    更新日期:2013-10-01 00:00:00

  • Simulation of fractograms of fat emulsions in power-programmed sedimentation field-flow fractionation (SdFFF).

    abstract::A quasi-empirical approach to the simulation of fractograms was examined to verify that the elution behavior of emulsions in power-based field programmed sedimentation field-flow fractionation (SdFFF) is consistent and predictable. The approach was applied to Intralipid, a commercial soybean emulsion and to an investi...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(95)01313-a

    authors: Levin S,Nudelman R,Reschiglian P,Pasti L

    更新日期:1995-06-01 00:00:00

  • Square wave adsorptive stripping voltammetric determination of piromidic acid. Application in urine.

    abstract::A simple procedure for the determination of piromidic acid by square wave adsorptive stripping voltammetry (SW-AdSV) at a hanging mercury drop electrode has been developed. The variables affecting to accumulation process such as concentration of perchloric acid, accumulation potential and accumulation time have been o...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(03)00306-6

    authors: Guiberteau Cabanillas A,Ortiz Burguillos JM,Martínez Cañas MA,Rodríguez Cáceres MI,Salinas López F

    更新日期:2003-11-24 00:00:00

  • Following-up skin penetration of lidocaine from different vehicles by Raman spectroscopic mapping.

    abstract::The application of local anesthetics, usually administered by subcutaneous injection, is common in the course of diagnostic, therapeutic, and cosmetic dermatology procedures. The effective dermal delivery of lidocaine could offer a solution to many adverse effects caused by needle insertion, such as pain, local reacti...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2018.02.056

    authors: Bakonyi M,Gácsi A,Kovács A,Szűcs MB,Berkó S,Csányi E

    更新日期:2018-05-30 00:00:00

  • Liquid chromatographic-tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydrochlorothiazide in human plasma.

    abstract::A rapid and sensitive method using liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been developed for the simultaneous determination of telmisartan and hydrochlorothiazide in human plasma. Sample preparation involved liquid-liquid extraction with diethyl ether-dichloromethane (60:40, v/v). The analytes a...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2008.08.021

    authors: Yan T,Li H,Deng L,Guo Y,Yu W,Fawcett JP,Zhang D,Cui Y,Gu J

    更新日期:2008-12-01 00:00:00

  • Spectrophotometric determination of silicate traces in hemodialysis solutions.

    abstract::Reliable methods for the analysis of silicon are of great importance, because it seems that the silicate anion can reduce aluminum bioavailability in patients undergoing dialysis. Thus, a simple and sensitive spectrophotometric method is described for the determination of silicate traces in dialysis solutions. The met...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(99)00054-0

    authors: Raggi MA,Sabbioni C,Mandrioli R,Zini Q,Varani G

    更新日期:1999-06-01 00:00:00

  • A new approach to evaluate stability of amodiaquine and its metabolite in blood and plasma.

    abstract::A stability study for amodiaquine (AQ) and desethylamodiaquine (AQm) in whole blood and plasma is reported. AQ, AQm and chloroquine (CQ) were simultaneously analysed and the ratios AQ/CQ and AQm/CQ were used to ensure correct interpretation of the stability results. CQ was stable in whole blood and plasma at all teste...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2005.10.018

    authors: Blessborn D,Neamin G,Bergqvist Y,Lindegårdh N

    更新日期:2006-04-11 00:00:00

  • Optical purity determination and (1)H-NMR spectral simplification with lanthanide shift reagents - VIII. An indacrinone precursor, 6,7-dichloro-5-methoxy-2-methyl-2-phenyl-1-indanone.

    abstract::The 60 MHz (1)H NMR spectra of racemic 6,7-dichloro-5-methoxy-2-methyl-2-phenyl-1 indanone (1) have been studied with the achiral shift reagent, tris(6,6,7,7,8,8,8-heptafluoro-2,2-dimethyl-3,5-octanedionato) europium (III) (2) and the chiral reagents, tris[3-(trifluoromethylhydroxymethylene)-d-camphorato] europium (II...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(86)80065-6

    authors: Hatzis A,Rothchild R

    更新日期:1986-01-01 00:00:00

  • Fully automated assay for the determination of GR117289X in human plasma using mixed mode solid-phase extraction and high-performance liquid chromatography with ultraviolet detection.

    abstract::GR117289X, 3-(3-Bromo-2-[2-(1H-tetrazol-5-yl)-phenyl]-bezofuran-5-yl methyl)-2-butyl- 5-chloro-3H-imidazole-4-carboxylic acid, 1, is an angiotensin II receptor antagonist. A sensitive, accurate and precise assay for the determination of 1 in human plasma and validation data is described. The assay consists of a novel ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(94)e0032-v

    authors: Murkitt GS,Trafankowska EZ,Dunne M,Manchee GR

    更新日期:1994-09-01 00:00:00

  • Determination of morphine and codeine in urine by gas chromatography-mass spectrometry.

    abstract::GC-MS is one of the recommended analytical techniques for the identification and confirmation of opiates in urine. A method for the qualitative detection and quantitation of codeine and morphine in urine samples by this technique has been developed. This method is also suitable for the detection of their main metaboli...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(90)80140-k

    authors: Solans A,de la Torre R,Segura J

    更新日期:1990-01-01 00:00:00

  • Enantioselective determination of felodipine in human plasma by chiral normal-phase liquid chromatography and electrospray ionisation mass spectrometry.

    abstract::An analytical method was developed for the determination of the enantiomers of felodipine, a dihydropyridine-type calcium antagonist, in human blood plasma. Felodipine was extracted from plasma using toluene as extraction solvent. The enantiomers were separated on a cellulose tris(4-methyl benzoate) stationary phase (...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(01)00582-9

    authors: Lindmark B,Ahnoff M,Persson BA

    更新日期:2002-01-15 00:00:00

  • High-performance liquid chromatographic separation of paclitaxel intermediate phenylisoserine derivatives on macrocyclic glycopeptide and cyclofructan-based chiral stationary phases.

    abstract::High-performance liquid chromatographic methods were developed for the separation of enantiomers of four unnatural paclitaxel precursor phenylisoserine analogs on chiral stationary phases containing macrocyclic glycopeptides and cyclofructans as chiral selectors. The effects of the mobile phase composition, the nature...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2015.06.007

    authors: Ilisz I,Grecsó N,Forró E,Fülöp F,Armstrong DW,Péter A

    更新日期:2015-10-10 00:00:00

  • Quantitative risk assessment in classification of drugs with identical API content.

    abstract::When combating counterfeits it is equally important to recognize fakes and to avoid misclassification of genuine samples. This study presents a general approach to the problem using a newly-developed method called Data Driven Soft Independent Modeling of Class Analogy. The possibility to collect representative data fo...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2014.05.033

    authors: Rodionova OY,Balyklova KS,Titova AV,Pomerantsev AL

    更新日期:2014-09-01 00:00:00

  • Electrochemical monitoring of piroxicam in different pharmaceutical forms with multi-walled carbon nanotubes paste electrode.

    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

    authors: Abbaspour A,Mirzajani R

    更新日期:2007-05-09 00:00:00

  • HPLC method for the determination of fluvoxamine in human plasma and urine for application to pharmacokinetic studies.

    abstract::A simple, specific and sensitive high-performance liquid chromatographic (HPLC) method has been developed for the assay of fluvoxamine in human plasma and urine. The method was based on reaction of fluvoxamine with 1,2-naphthoquinone-4-sulphonic acid sodium salt (NQS) forming orange colored product. The fluvoxamine-NQ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2006.11.005

    authors: Ulu ST

    更新日期:2007-03-12 00:00:00

  • Application of monolithic column in quantification of gliclazide in human plasma by liquid chromatography.

    abstract::A simple, rapid and sensitive isocratic reversed phase HPLC method with UV detection using a monolithic column has been developed and validated for the determination of gliclazide in human plasma. The assay enables the measurement of gliclazide for therapeutic drug monitoring with a minimum quantification limit of 10n...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 临床试验,杂志文章

    doi:10.1016/j.jpba.2006.05.003

    authors: Foroutan SM,Zarghi A,Shafaati A,Khoddam A

    更新日期:2006-10-11 00:00:00

  • Separation of stereoisomers of sertraline and its related enantiomeric impurities on a dimethylated beta-cyclodextrin stationary phase by HPLC.

    abstract::A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for evaluating the chiral discrimination ability of CYCLOBOND I 2000 DM chiral stationary phase (CSP) towards sertraline and its related enantiomers. The effect of pH, buffer concentration as well as nature of organic mo...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2009.04.038

    authors: Rao RN,Talluri MV,Maurya PK

    更新日期:2009-10-15 00:00:00

  • Quantitative analysis of flavonoids, alkaloids and saponins of Banxia Xiexin decoction using ultra-high performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry.

    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

    authors: Wang Y,Xu R,Xiao J,Zhang J,Wang X,An R,Ma Y

    更新日期:2014-01-01 00:00:00

  • Polarographic determination of phenytoin and benzophenone (as impurity) in pharmaceutical preparations.

    abstract::A differential pulse polarographic method is described for detection and trace determination of benzophenone (the main impurity) in phenytoin powder. The method depends upon the polarographic activity of benzophenone in Britton-Robinson buffer pH 5.6. The limit of detection was found to be 2.5 x 10(-6) microg ml(-1). ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(01)00669-0

    authors: Razak OA,Gazy AA,Wahbi AM

    更新日期:2002-05-15 00:00:00

  • In vitro evaluation of reactive nature of E- and Z-guggulsterones and their metabolites in human liver microsomes using UHPLC-Orbitrap mass spectrometer.

    abstract::Guggulipid is known to be useful for hypercholesterolemia, arthritis, acne, and obesity. These activities are attributed to its two principal isomeric active constituents, viz., E- and Z-guggulsterones. There are several side effects reported for guggulipid, which include widespread erythematous papules in a morbillif...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113275

    authors: Balhara A,Ladumor M,Singh DK,Praneetha P,Preethi J,Pokharkar S,Deshpande AY,Giri S,Singh S

    更新日期:2020-07-15 00:00:00

  • Rapid determination of recent cocaine use with magnetic particles-based enzyme immunoassays in serum, saliva, and urine fluids.

    abstract::Cocaine is one of the most worldwide used illicit drugs. We report a magnetic particles-based enzyme-linked immunoassay (mpEIA) method for the rapid and sensitive determination of cocaine (COC) in saliva, urine and serum samples. Under optimized conditions, the limits of detections were 0.09ngmL(-1) (urine), 0.15ngmL(...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2016.03.004

    authors: Vidal JC,Bertolín JR,Bonel L,Asturias L,Arcos-Martínez MJ,Castillo JR

    更新日期:2016-06-05 00:00:00

  • Pharmacokinetics of osthole in rat plasma using high-performance liquid chromatography.

    abstract::A simple high-performance liquid chromatographic method was developed to study the pharmacokinetics of osthole in rat plasma. After addition of an internal standard (paeonol), plasma was deproteinized by acetonitrile for sample clean-up. The drugs were separated on a reversed-phase column and detected by UV absorption...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(95)01692-9

    authors: Tsai TH,Tsai TR,Chen CC,Chen CF

    更新日期:1996-04-01 00:00:00

  • A simple HPLC method using a microbore column for the analysis of doxorubicin.

    abstract::Doxorubicin is one of the most potent anti-tumor agents generally used in the treatment of bone cancer. A simple and sensitive HPLC method was developed and validated for the assay of doxorubicin. The method used a C18 Luna microbore column (50 x 1 mm) with a fluorescent detector (505 nm Ex. and 550 nm Em.). The mobil...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(99)00070-9

    authors: Zhao P,Dash AK

    更新日期:1999-07-01 00:00:00

  • Analysis of gentamicin by liquid chromatography with pulsed electrochemical detection.

    abstract::The analysis of gentamicin by liquid chromatography using a column packed with poly(styrene-divinylbenzene) and pulsed electrochemical detection on a gold electrode is described. The mobile phase consists of an aqueous solution containing sodium sulfate, tetrahydrofuran, sodium 1-octanesulfonate and a phosphate buffer...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(98)00214-3

    authors: Adams E,Roelants W,De Paepe R,Roets E,Hoogmartens J

    更新日期:1998-12-01 00:00:00

  • Separation window dependent multiple injection (SWDMI) for large scale analysis of therapeutic antibody N-glycans.

    abstract::There is a growing demand in the biopharmaceutical industry for large scale N-glycosylation analysis of biotherapeutics, especially monoclonal antibodies. To fulfill this high throughput analysis requirement with single column separation systems in most instances require finishing the entire analysis cycle including c...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2016.06.002

    authors: Kovács Z,Szarka M,Szigeti M,Guttman A

    更新日期:2016-09-05 00:00:00

  • Application of simple on-line sweeping sample concentration technique coupled micellar electrokinetic chromatography for simultaneous analysis of estrogen and androgen epimer.

    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

    authors: Cheng C,Tsai HR

    更新日期:2011-12-05 00:00:00

  • NMR and Bayesian regularized neural network regression for impurity determination of 4-aminophenol.

    abstract::A method for the determination of 4-aminophenol as an impurity in paracetamol (N-(4-hydroxyphenyl)-acetamide) by proton nuclear magnetic resonance ((1)H-NMR) spectroscopy has been developed. The (13)C-satellite from the protons in the ortho position from the hydroxyl group in paracetamol was used as an internal standa...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(02)00086-9

    authors: Forshed J,Andersson FO,Jacobsson SP

    更新日期:2002-07-01 00:00:00

  • Liquidambar styraciflua L.: A new potential source for therapeutic uses.

    abstract::Liquidambar styraciflua L., ALTINGIACEAE, popularly known as sweet gum or alligator tree, is an aromatic tree with a natural distribution in North America and acclimated in Brazil. In traditional medicine, L. styraciflua L is used for the treatment of stomach disorders, wounds, and coughs. The present study was design...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2019.06.003

    authors: Mancarz GFF,Laba LC,da Silva ECP,Prado MRM,de Souza LM,de Souza D,Nakashima T,Mello RG

    更新日期:2019-09-10 00:00:00

  • Development of a multi-matrix LC-MS/MS method for urea quantitation and its application in human respiratory disease studies.

    abstract::In human respiratory disease studies, liquid samples such as nasal secretion (NS), lung epithelial lining fluid (ELF), or upper airway mucosal lining fluid (MLF) are frequently collected, but their volumes often remain unknown. The lack of volume information makes it hard to estimate the actual concentration of recove...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2016.11.001

    authors: Wang J,Gao Y,Dorshorst DW,Cai F,Bremer M,Milanowski D,Staton TL,Cape SS,Dean B,Ding X

    更新日期:2017-01-30 00:00:00

  • Analysis of multiple constituents in a Chinese herbal preparation Shuang-Huang-Lian oral liquid by HPLC-DAD-ESI-MSn.

    abstract::A high-performance liquid chromatography/mass spectrometry (HPLC-MS) method for the quality control of Shuang-Huang-Lian oral liquid, an antimicrobial and antipyretic herbal preparation, has been developed. Pure compounds are subjected to tandem mass spectrometry (MS(n)) analysis to clarify their fragmentation rules. ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2007.02.023

    authors: Han J,Ye M,Guo H,Yang M,Wang BR,Guo DA

    更新日期:2007-06-28 00:00:00