Forced degradation and impurity profiling: Recent trends in analytical perspectives

Journal of Pharmaceutical and Biomedical Analysis

Volumn 86, Issue , 2013, Pages 11-35

  Jain, Deepti ^a   Basniwal, Pawan Kumar ^a,b  

^a UNIVERSITY INSTITUTE OF TECHNOLOGY   (India)

^b Bharat Sewak Shiksha Samiti   (India)

Author keywords

Active pharmaceutical ingredient; Analytical perspectives; Drug products; Forced degradation profiling; Impurity

Indexed keywords

ACETAZOLAMIDE; ACETYLSPIRAMYCIN; ALIZAPRIDE; ALMOTRIPTAN; BETAHISTINE; BETAMETHASONE DIPROPIONATE; BICALUTAMIDE; CLINDAMYCIN PALMITATE; CLOPIDOGREL; DESLORATADINE; DEXAMETHASONE; DONEPEZIL; ECONAZOLE; ENALAPRIL MALEATE; EPIRUBICIN; GINKGOLIDE B; GLIMEPIRIDE; MEPIRODIPINE; MONTELUKAST; NEVIRAPINE; OMEPRAZOLE; PIPECURONIUM BROMIDE; PRIDINOL MESILATE; RABEPRAZOLE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SALICYLIC ACID; TARANABANT; UNINDEXED DRUG; VALSARTAN; ZAFIRLUKAST;

ANALYTIC METHOD; CAPILLARY ELECTROPHORESIS; CHEMICAL COMPOSITION; DRUG DEGRADATION; DRUG DETERMINATION; DRUG DOSAGE FORM; DRUG IMPURITY; ELUTION; FLUORESCENCE; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; PROCESS DEVELOPMENT; QUANTITATIVE ANALYSIS; REVIEW; THIN LAYER CHROMATOGRAPHY;

(1)H NMR; (13)C NMR; 1,1,1,3,3,3-HEXAFLUOROISOPROPANOL; 1,1,2-TRICHLORO ETHANE; 13 CARBON NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; 1D/2D NMR; 3,4-METHYLENEDIOXY-N-METHYLAMPHETAMINE; AAMRT; ACETONITRILE; ACN; ACTIVE PHARMACEUTICAL INGREDIENT; AMMONIA; AMMONIUM ACETATE; AMMONIUM DIHYDROGEN PHOSPHATE; AMMONIUM FORMATE; AMMONIUM HYDROXIDE; ANALYTICAL PERSPECTIVES; APCI-MS; API; ATMOSPHERIC-PRESSURE CHEMICAL-IONIZATION MASS SPECTROMETRY; AUTO-ASSOCIATIVE MULTIVARIATE REGRESSION TREES; BADGE; BEH; BENZENE; BISPHENOL A DIGLYCIDYL ETHER; BRIDGED ETHYLENE HYBRID; C(6)H(6); CAD; CAPILLARY ELECTROPHORESIS; CARBON DIOXIDE; CCD; CCL(4); CE; CEAD; CENTRAL COMPOSITE DESIGN; CH(2)CL(2); CH(3)COONH(4); CHARGED AEROSOL DETECTOR; CHCL(2)CH(2)CL; CHCL(3); CHLOROFORM; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; CID; CO(2); COLLISION-INDUCED DISSOCIATION; COPD; COULOMETRIC ELECTRODE ARRAY DETECTION; DAD/MS; DEPT; DIODE ARRAY DETECTOR-MASS SPECTROMETRY; DIPOTASSIUM HYDROGEN PHOSPHATE; DISODIUM PHOSPHATE; DISTORTIONLESS ENHANCEMENT BY POLARIZATION TRANSFER; DRUG PRODUCTS; EDTA; ELECTRONSPRAY IONIZATION MULTI-STAGE OR TANDEM MASS SPECTROMETRY; ELECTROSPRAY IONIZATION FOURIER TRANSFORM ION CYCLOTRON RESONANCE MASS SPECTROMETRY; ELECTROSPRAY IONIZATION, COLLISION-INDUCED DISSOCIATION AND TANDEM MASS SPECTROMETRY; ELSD; EMEA; ESI-CID-MS/MS; ESI-FTICR-MS; ESI/MS(N); ETHYLENE DIAMINE TETRA ACETIC ACID; EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS; EVAPORATIVE LIGHT SCATTERING DETECTOR; FORCED DEGRADATION PROFILING; FORMIC ACID; FOURIER TRANSFORM INFRARED; FOURIER TRANSFORM ION CYCLOTRON RESONANCE; FT-IR; FTICR; GAS CHROMATOGRAPHY-FLAME IONIZATION DETECTOR; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; GC-FID; GC-MS; GEL FILTRATION CHROMATOGRAPHY; GENOTOXIC IMPURITIES; GFC; GTIS; H(2)O; H(3)PO(4); HCL; HCOOH; HCOONH(4); HEADSPACE SOLID PHASE MICROEXTRACTION; HEIP; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY; HIGH-PERFORMANCE ANION-EXCHANGE CHROMATOGRAPHY-INTEGRATED PULSED AMPEROMETRIC DETECTION; HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY/ELECTROSPRAY IONIZATION MASS SPECTROMETRY; HIGH-PERFORMANCE SIZE-EXCLUSION CHROMATOGRAPHY; HILIC; HP-SEC; HPAE-IPAD; HPLC; HPLC/ESI-MS; HPTLC; HYDROCHLORIC ACID; HYDROPHILIC INTERACTION CHROMATOGRAPHY; ICH; IFM; IMPURITY; IMPURITY FATE MAPPING; IND; INTERNATIONAL CONFERENCE ON HARMONIZATION; INVESTIGATIONAL NEW DRUGS; IPA; ISOPROYL ALCOHOL; K(2)HPO(4); KH(2)PO(4); KOH; LC-ESI-MS(N); LC-ESI-QT/MS/MS; LC-MS; LC/MS/MS; LICL; LIQUID CHROMATOGRAPHY-ELECTRO SPRAY IONIZATION-TANDEM MASS SPECTROMETER; LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY; LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY; LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY USING ELECTROSPRAY IONIZATION SOURCE AND Q-TRAP MASS ANALYZER; LITHIUM CHLORIDE; MASS SPECTROMETRY; MDMA; MECC; MEDIUM PRESSURE LIQUID CHROMATOGRAPHY; MEKC; MEOH; METHANOL; METHYLENE CHLORIDE; MICELLAR ELECTROKINETIC CAPILLARY CHROMATOGRAPHY; MICELLAR ELECTROKINETIC CHROMATOGRAPHY; MPLC; MPTP; MS; N-METHYL-4-PHENYL-1,2,3,6-TETRAHYDROPYRIDINE; NA(2)HPO(4); NA(3)PO(4); NACL; NDA; NEW DRUG APPLICATION; NH(3); NH(4)H(2)PO(4); NH(4)OH; NOESY; NON-STEROIDAL ANTI-INFLAMMATORY DRUGS; NSAIDS; NUCLEAR OVERHAUSER EFFECT SPECTROSCOPY; ONE DIMENSIONAL/TWO DIMENSIONAL NUCLEAR MAGNETIC RESONANCE; ORGANIC VOLATILE IMPURITIES; OVIS; PCA; PDA; PDA-MS; PENTAFLUOROPROPIONIC ACID ANHYDRIDE; PFPA; PHOSPHORIC ACID; PHOTODIODE ARRAY; PHOTODIODE ARRAY DETECTOR-MASS SPECTROMETRY; POTASSIUM DIHYDROGEN PHOSPHATE; POTASSIUM HYDROXIDE; PRINCIPAL COMPONENT ANALYSIS; PROTON NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; Q-TOF; QUADRUPOLE-TIME-OF-FLIGHT; REFRACTIVE INDEX; RELATIVE RESPONSE FACTOR; RI; RRF; SDS; SDS-PAGE; SFC; SODIUM CHLORIDE; SODIUM DODECYL SULFATE; SODIUM DODECYL SULFATE POLYACRYLAMIDE GEL ELECTROPHORESIS; SODIUM PHOSPHATE; SPME; SUPERCRITICAL FLUID CHROMATOGRAPHY; TEA; TETRACHLOROMETHANE; TFA; TRIETHYLAMINE; TRIFLUOROACETIC ACID; TRIS; TRISAMINOMETHANE; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; UPLC; US FOOD AND DRUG ADMINISTRATION; USFDA; WATER;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; HUMANS; PHARMACEUTICAL PREPARATIONS;

EID: 84883007411     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.07.013     Document Type: Review

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124. Milanowskia D.J., Keilmana J., Guob C., Mocek U. Isolation and identification of five impurities of ALB 109564(a) drug substance. Journal of Pharmaceutical and Biomedical Analysis 2011, 55:366-372.
125. Sitaram C., Rupakula R., Reddy B.N. Determination and characterization of degradation products of anastrozole by LC-MS/MS and NMR spectroscopy. Journal of Pharmaceutical and Biomedical Analysis 2011, 56:962-968.
126. Stringham R.W., Pennell M., Cabric W., Carzanac G., Giorgic F., Lalli S., Marazzic G., Torri M. Identification of impurities in artemisinin, their behavior in high performance liquid chromatography and implications for the quality of derived anti-malarial drugs. Journal of Chromatography A 2011, 1218:6838-6842.
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128. Li Y.G., Chen H.F., Tu M.Z., Zhang P.Z., Wang X.Y. Identification, synthesis and quantification of process-related impurities in auraptene. Journal of Pharmaceutical and Biomedical Analysis 2011, 56:191-199.
129. Dick L., Dooley N., Elliott M.A., Ford S.J., Gordon M.R., Halbert G.W., Kerr W.J. Boron phenylalanine and related impurities: HPLC analysis, stability profile and degradation pathways. Journal of Pharmaceutical and Biomedical Analysis 2011, 56:633-636.
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131. Thomas S., Mathela C.S., Agarwal A., Paul S.K. Identification and structural elucidation of an unknown impurity in carbamazepine active pharmaceutical ingredient by liquid chromatography-tandem mass spectrometry and semi-preparative chromatographic isolation. Journal of Pharmaceutical and Biomedical Analysis 2011, 56:423-428.
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145. Rystov L., Chadwick R., Krock K., Wang T. Simultaneous determination of Maillard reaction impurities in memantine tablets using HPLC with charged aerosol detector. Journal of Pharmaceutical and Biomedical Analysis 2011, 56:887-894.
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164. Gupta L.K. Spectroscopic characterization and quantitative determination of atorvastatin calcium impurities by novel HPLC method. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 2012, 97:495-501.
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