title: 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.
authors: School of Pharmaceutical Sciences, Rajiv Gandhi Technological University, Bhopal 462 033, Madhya Pradesh, India. Electronic address: deepti2515@yahoo.com.
authors: Deepti
authors: D
authors: Jain
authors: Pawan Kumar
authors: PK
authors: Basniwal
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000639:trends*; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000639:trends; D004340:Drug Contamination; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*
chemical_list: D004364:Pharmaceutical Preparations
keywords: (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; ACN; APCI-MS; API; Analytical perspectives; BADGE; BEH; C(6)H(6); CAD; CCD; CCl(4); CE; CEAD; CH(2)Cl(2); CH(3)COONH(4); CHCl(2)CH(2)Cl; CHCl(3); CID; CO(2); COPD; DAD/MS; DEPT; Drug products; EDTA; ELSD; EMEA; ESI-CID-MS/MS; ESI-FTICR-MS; ESI/MS(n); European agency for the evaluation of medicinal products; FT-IR; FTICR; Forced degradation profiling; Fourier transform infrared; Fourier transform ion cyclotron resonance; GC-FID; GC–MS; GFC; GTIs; H(2)O; H(3)PO(4); HCOOH; HCOONH(4); HCl; HEIP; HILIC; HP-SEC; HPAE-IPAD; HPLC; HPLC/ESI-MS; HPTLC; ICH; IFM; IND; IPA; Impurity; International Conference on Harmonization; K(2)HPO(4); KH(2)PO(4); KOH; LC/MS/MS; LC–ESI-MS(n); LC–ESI-QT/MS/MS; LC–MS; LiCl; MDMA; MECC; MEKC; MPLC; MPTP; MS; MeOH; N-methyl-4-phenyl-1,2,3,6-tetrahydropyridine; NDA; NH(3); NH(4)H(2)PO(4); NH(4)OH; NOESY; NSAIDs; Na(2)HPO(4); Na(3)PO(4); NaCl; New Drug Application; OVIs; PCA; PDA; PDA-MS; PFPA; Q-TOF; RI; RRF; SDS; SDS-PAGE; SFC; SPME; TEA; TFA; Tris; UPLC; US Food and Drug Administration; USFDA; acetonitrile; active pharmaceutical ingredient; ammonia; ammonium acetate; ammonium dihydrogen phosphate; ammonium formate; ammonium hydroxide; atmospheric-pressure chemical-ionization mass spectrometry; auto-associative multivariate regression trees; benzene; bisphenol A diglycidyl ether; bridged ethylene hybrid; capillary electrophoresis; carbon dioxide; central composite design; charged aerosol detector; chloroform; chronic obstructive pulmonary disease; collision-induced dissociation; coulometric electrode array detection; diode array detector-mass spectrometry; dipotassium hydrogen phosphate; disodium phosphate; distortionless enhancement by polarization transfer; 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; ethylene diamine tetra acetic acid; evaporative light scattering detector; formic acid; gas chromatography-flame ionization detector; gas chromatography–mass spectrometry; gel filtration chromatography; genotoxic impurities; headspace solid phase microextraction; 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; hydrochloric acid; hydrophilic interaction chromatography; impurity fate mapping; investigational new drugs; isoproyl alcohol; 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; medium pressure liquid chromatography; methanol; methylene chloride; micellar electrokinetic capillary chromatography; micellar electrokinetic chromatography; non-steroidal anti-inflammatory drugs; nuclear overhauser effect spectroscopy; one dimensional/two dimensional nuclear magnetic resonance; organic volatile impurities; pentafluoropropionic acid anhydride; phosphoric acid; photodiode array; photodiode array detector-mass spectrometry; potassium dihydrogen phosphate; potassium hydroxide; principal component analysis; proton nuclear magnetic resonance spectroscopy; quadrupole-time-of-flight; refractive index; relative response factor; sodium chloride; sodium dodecyl sulfate; sodium dodecyl sulfate polyacrylamide gel electrophoresis; sodium phosphate; supercritical fluid chromatography; tetrachloromethane; triethylamine; trifluoroacetic acid; trisaminomethane; ultra performance liquid chromatography; water