Assessing mass balance in pharmaceutical drug products: New insights into an old topic

[1]  M. Jamrógiewicz,et al.  Detection of some volatile degradation products released during photoexposition of ranitidine in a solid state. , 2013, Journal of pharmaceutical and biomedical analysis.

[2]  Stephen R. Groskreutz,et al.  Theory and Practice of Two‐Dimensional Liquid Chromatography Separations Involving the HILIC Mode of Separation , 2013 .

[3]  Werner Weitschies,et al.  Changes in recovery due to drug product matrix ageing as a source of mass imbalances. , 2013, Journal of pharmaceutical and biomedical analysis.

[4]  B. Olsen,et al.  Hydrophilic Interaction Chromatography: A Guide for Practitioners , 2013 .

[5]  Ulrike Holzgrabe,et al.  Charged aerosol detection in pharmaceutical analysis. , 2012, Journal of pharmaceutical and biomedical analysis.

[6]  Joanne R. Bone,et al.  Liquid chromatography-flame ionisation detection using a nebuliser/spray chamber interface. Part 2. Comparison of functional group responses. , 2012, Journal of chromatography. A.

[7]  I. Hewala,et al.  New concept for HPTLC peak purity assessment and identification of drugs in multi-component mixtures. , 2012, Talanta.

[8]  Chai Yuan Tat,et al.  Stability-indicating micellar electrokinetic chromatography method for the analysis of sumatriptan succinate in pharmaceutical formulations. , 2011, Journal of pharmaceutical and biomedical analysis.

[9]  J. M. Babu,et al.  Characterization and relative response factor determination of process related impurity in Naproxen by nuclear magnetic resonance spectroscopy. , 2011, Journal of pharmaceutical and biomedical analysis.

[10]  U. Holzgrabe,et al.  Identification and control of impurities in streptomycin sulfate by high-performance liquid chromatography coupled with mass detection and corona charged-aerosol detection. , 2011, Journal of pharmaceutical and biomedical analysis.

[11]  Frances Liu,et al.  Identification of pharmaceutical impurities in formulated dosage forms. , 2011, Journal of pharmaceutical sciences.

[12]  P. Haddad,et al.  Comparison of the response of four aerosol detectors used with ultra high pressure liquid chromatography. , 2011, Journal of chromatography. A.

[13]  K. Bothara,et al.  A validated RP-HPLC method for quantitative determination of related impurities of ursodeoxycholic acid (API) by refractive index detection. , 2011, Journal of pharmaceutical and biomedical analysis.

[14]  P. Haddad,et al.  Universal response model for a corona charged aerosol detector. , 2010, Journal of chromatography. A.

[15]  P. D. Tzanavaras,et al.  Recent Advances in the Analysis of Organic Impurities of Active Pharmaceutical Ingredients and Formulations: A Review , 2010 .

[16]  M. B. Mackaplow Using a Mass Balance to Determine the Potency Loss during the Production of a Pharmaceutical Blend , 2010, AAPS PharmSciTech.

[17]  K. V. Surendranath,et al.  Development and validation of a stability-indicating UHPLC method for assay of felbamate and related substances , 2010 .

[18]  Aleš Obreza,et al.  Review of operating principle and applications of the charged aerosol detector. , 2010, Journal of chromatography. A.

[19]  Kasa Srinivasulu,et al.  Development and validation of a stability indicating LC method for the assay and related substances determination of exemestane, an aromatase inhibitor. , 2009, Journal of pharmaceutical and biomedical analysis.

[20]  K. Chandrasekhar,et al.  A validated stability-indicating RP-HPLC method for levofloxacin in the presence of degradation products, its process related impurities and identification of oxidative degradant. , 2009, Journal of pharmaceutical and biomedical analysis.

[21]  M. Zečević,et al.  Study of forced degradation behavior of eletriptan hydrobromide by LC and LC-MS and development of stability-indicating method. , 2009, Journal of pharmaceutical and biomedical analysis.

[22]  C. M. Tyrakowski,et al.  Determination of relative response factors for chromatographic investigations using NMR spectrometry. , 2009, Journal of pharmaceutical and biomedical analysis.

[23]  B. Olsen,et al.  A simple and efficient approach to reversed-phase HPLC method screening. , 2009, Journal of pharmaceutical and biomedical analysis.

[24]  U. Tripathi,et al.  Stress Degradation Behavior of Entacapone and Development of LC Stability-Indicating Related Substances and Assay Method , 2009 .

[25]  K. Chandrasekhar,et al.  A Validated, Specific Stability-Indicating RP-LC Method for Moxifloxacin and Its Related Substances , 2009 .

[26]  M. Ravikumar,et al.  A Validated and Stability-Indicating LC Assay Method for Valdecoxib , 2009 .

[27]  R. Shah,et al.  Stability indicating validated HPLC method for quantification of levothyroxine with eight degradation peaks in the presence of excipients. , 2008, International journal of pharmaceutics.

[28]  P. Shah,et al.  The practical application of implementing the equimolar response principle of chemiluminescent nitrogen detection in pharmaceutical analysis. , 2008, Journal of pharmaceutical and biomedical analysis.

[29]  Pengzu Zhou,et al.  Direct stability-indicating method development and validation for analysis of etidronate disodium using a mixed-mode column and charged aerosol detector. , 2008, Journal of pharmaceutical and biomedical analysis.

[30]  C. Maryanoff,et al.  Determination of relative response factors of impurities in paclitaxel with high performance liquid chromatography equipped with ultraviolet and charged aerosol detectors. , 2008, Journal of chromatography. A.

[31]  Bernard A Olsen,et al.  Is HPLC assay for drug substance a useful quality control attribute? , 2007, Journal of pharmaceutical and biomedical analysis.

[32]  M. Suryanarayana,et al.  Development of an HPLC Assay Method for Lenalidomide , 2007 .

[33]  M. Suryanarayana,et al.  A Stability-Indicating LC Assay Method for Bicalutamide , 2007 .

[34]  G. R. Deshpande,et al.  A Rapid Stability-Indicating LC Method for Ziprasidone Hydrochloride , 2007 .

[35]  Karen M. Alsante,et al.  The role of degradant profiling in active pharmaceutical ingredients and drug products. , 2007, Advanced drug delivery reviews.

[36]  S. Baertschi Analytical methodologies for discovering and profiling degradation-related impurities , 2006 .

[37]  P. Madhavan,et al.  Development and validation of a specific stability indicating high performance liquid chromatographic method for rizatriptan benzoate. , 2006, Journal of pharmaceutical and biomedical analysis.

[38]  R. Put,et al.  Evaluation of chemometric techniques to select orthogonal chromatographic systems. , 2006, Journal of pharmaceutical and biomedical analysis.

[39]  J. Dolan,et al.  "Orthogonal" separations for reversed-phase liquid chromatography. , 2006, Journal of chromatography. A.

[40]  S. Baertschi,et al.  Role of ‘‘mass balance’’ in pharmaceutical stress testing , 2005 .

[41]  S. Gorog The sacred cow: the questionable role of assay methods in characterising the quality of bulk pharmaceuticals. , 2005 .

[42]  S. Jacobsson,et al.  Peak purity determination with principal component analysis of high-performance liquid chromatography-diode array detection data. , 2004, Journal of chromatography. A.

[43]  Karen M. Alsante,et al.  Handbook of Isolation and Characterization of Impurities in Pharmaceuticals , 2003 .

[44]  Saranjit Singh,et al.  Development of validated stability-indicating assay methods--critical review. , 2002, Journal of pharmaceutical and biomedical analysis.

[45]  M. Lovdahl,et al.  Synthesis and characterization of pregabalin lactose conjugate degradation products. , 2002, Journal of pharmaceutical and biomedical analysis.

[46]  S. Baertschi,et al.  Determination of relative UV response factors for HPLC by use of a chemiluminescent nitrogen-specific detector. , 2002, Journal of pharmaceutical and biomedical analysis.

[47]  D. L. Massart,et al.  Purity assessment and resolution of tetracycline hydrochloride samples analysed using high-performance liquid chromatography with diode array detection , 1999 .

[48]  C. Cramers,et al.  HPLC‐FID with Superheated Water as the Eluent: Improved Methods and Instrumentation , 1998 .

[49]  W. Neff,et al.  Correlation of reversed-phase high-performance liquid chromatography and gas—liquid chromatography for fatty acid compositions of some vegetable oils , 1993 .

[50]  S. Gharfeh,et al.  Automated high-performance liquid chromatography determination of hydrocarbon types in crude oil residues using a flame ionization detector , 1986 .

[51]  James F Cuff,et al.  Application of Heart-Cutting 2D-LC for the Determination of Peak Purity for a Chiral Pharmaceutical Compound by HPLC , 2012, Chromatographia.

[52]  K. Prajapati,et al.  STABILITY INDICATING HPLC METHOD DEVELOPMENT - A REVIEW , 2011 .

[53]  J. Satish,et al.  Original Research Papers Development and Validation of a Stability- Indicating UHPLC Method for Assay of Felbamate and Related Substances , 2010 .

[54]  P. Lukulay,et al.  A perspective on reconciling mass balance in forced degradation studies , 2005 .

[55]  S. Baertschi,et al.  Strategies for investigation and control of process- and degradation-related impurities , 2004 .

[56]  J. Dolan Resolving minor peaks , 2002 .

[57]  Dan W. Reynolds,et al.  Available guidance and best practices for conducting force degradation studies , 2002 .

[58]  Saranjit Singh,et al.  Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs , 2000 .

[59]  A. A. Priestner Use of radiolabelled drug substance to investigate mass balance during validation of a high-performance liquid chromatography method for impurities , 1993 .