Analytical quality by design for gas chromatographic method development
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Gautam Singhvi | Amit Alexander | Sunil Kumar Dubey | Siddhanth Hejmady | Rajesh Pradhan | S. Dubey | A. Alexander | Gautam Singhvi | Siddhanth Hejmady | Rajesh Pradhan
[1] Sandra Furlanetto,et al. Development of a capillary electrophoresis method for the assay of ramipril and its impurities: an issue of cis-trans isomerization. , 2011, Journal of chromatography. A.
[2] Z. Z. Sultanov. Production of lithocholic acid by partial synthesis , 2004, Pharmaceutical Chemistry Journal.
[3] Sandra Furlanetto,et al. Application of quality by design to the development of analytical separation methods , 2012, Analytical and Bioanalytical Chemistry.
[4] Frederick G. Vogt,et al. A Systematic Method Development Strategy for Quantitative Color Measurement in Drug Substances, Starting Materials, and Synthetic Intermediates , 2011, Journal of Pharmaceutical Innovation.
[5] Ntsomboh-Ntsefong Godswill,et al. GC-FID Method Development and Validation Parameters for Analysis of Palm Oil ( Elaeis guineensis Jacq.) Fatty Acids Composition , 2014 .
[6] Marion J. Chatfield,et al. Design and analysis of method equivalence studies. , 2009, Analytical chemistry.
[7] Hardik Patel,et al. A Comprehensive Review on Quality by Design (QbD) in Pharmaceuticals , 2013 .
[8] Vicki J. Barwick,et al. Sources of uncertainty in gas chromatography and high-performance liquid chromatography , 1999 .
[9] N. Vishal Gupta,et al. A Review on quality by design approach (QBD) for Pharmaceuticals , 2015 .
[10] Sagar Suman Panda,et al. Implementation of Quality by Design Approach for Developing Chromatographic Methods with Enhanced Performance: A Mini Review , 2016 .
[11] Mahfoozur Rahman,et al. Quality-by-design approach as a systematic tool for the development of nanopharmaceutical products. , 2019, Drug discovery today.
[12] M. Klee,et al. Theoretical and practical aspects of fast gas chromatography and method translation. , 2002, Journal of chromatographic science.
[13] S. Dubey,et al. QbD-driven development and validation of HPLC method for determination of Bisphenol A and Bis-sulphone in environmental samples , 2020, International Journal of Environmental Analytical Chemistry.
[14] E. Rozet,et al. Innovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space. , 2011, Journal of chromatography. A.
[15] Bernard A Olsen,et al. A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603). , 2008, Journal of pharmaceutical and biomedical analysis.
[16] Frederick G Vogt,et al. Development of quality-by-design analytical methods. , 2011, Journal of pharmaceutical sciences.
[17] S Furlanetto,et al. Mixture-process variable approach to optimize a microemulsion electrokinetic chromatography method for the quality control of a nutraceutical based on coenzyme Q10. , 2012, Talanta.
[18] Sandra Furlanetto,et al. Pitfalls and success of experimental design in the development of a mixed MEKC method for the analysis of budesonide and its impurities , 2009, Electrophoresis.
[19] Sarwar Beg,et al. Pharmaceutical QbD: Omnipresence in the product development lifecycle , 2017 .
[20] B. Shapiro,et al. Pre-clinical compartmental pharmacokinetic modeling of 2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a (HPPH) as a photosensitizer in rat plasma by validated HPLC method , 2019, Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology.
[21] Av Ganorkar,et al. Analytical Quality by Design: A Mini Review , 2017 .
[22] P. Marriott,et al. Influence of chromatographic conditions on separation in comprehensive gas chromatography. , 2002, Journal of chromatography. A.
[23] Simon J. Bale,et al. Quality by Design for Analytical Methods , 2010 .
[24] Sharmada S. Sinai Kakodkar,et al. Pharmaceutical Quality-by-Design (QbD): Basic Principles , 2015 .
[25] O. Coskun. Separation techniques: Chromatography , 2016, Northern clinics of Istanbul.
[26] David Q. Liu,et al. A Systematic Method Development Strategy for Determination of Pharmaceutical Genotoxic Impurities , 2010 .
[27] Suman Sood,et al. Method development and validation using HPLC technique – A review , 2014 .
[28] G. L. Reid,et al. REVERSED-PHASE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT IN AN ANALYTICAL QUALITY BY DESIGN FRAMEWORK , 2013 .
[29] B. Jahnavi,et al. QbD Considerations for Analytical Development , 2019, Pharmaceutical Quality by Design.
[30] T. Kupiec. Quality-control analytical methods: gas chromatography. , 2004, International journal of pharmaceutical compounding.
[31] A. Welankiwar,et al. Method development by liquid chromatography with validation , 2014 .
[32] Nafisur Rahman,et al. Analytical techniques in pharmaceutical analysis: A review , 2017 .
[33] Ramalingam Peraman,et al. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics , 2015, International journal of analytical chemistry.
[34] A. Parczewski,et al. Analytical methods for residual solvents determination in pharmaceutical products. , 2010, Acta poloniae pharmaceutica.
[35] S. Dubey,et al. Pre-clinical pharmacokinetic-pharmacodynamic modelling and biodistribution studies of donepezil hydrochloride by a validated HPLC method , 2018, RSC advances.
[36] I. Molnár,et al. Aspects of the "Design Space" in high pressure liquid chromatography method development. , 2010, Journal of chromatography. A.
[37] Ashish Chauhan,et al. GC-MS Technique and its Analytical Applications in Science and Technology , 2014 .
[38] S. Dubey,et al. Rapid and Sensitive Reverse-phase High-performance Liquid Chromatography Method for Estimation of Ketorolac in Pharmaceuticals Using Weighted Regression , 2013, Indian journal of pharmaceutical sciences.
[39] J. S. Hunter,et al. The 2 k — p Fractional Factorial Designs , 1961 .
[40] P. Borman,et al. Acceptance criteria for method equivalency assessments. , 2009, Analytical chemistry.
[41] V. Gupta,et al. HPLC : Isocratic or Gradient Elution and Assessment of Linearity In Analytical Methods , 2012 .