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Original Articles

Application of chemometric modelling to UV-Vis spectroscopy: development of simultaneous API and critical excipient assay in a liquid solution continuous flow

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Pages 919-929 | Received 30 Oct 2019, Accepted 14 May 2020, Published online: 04 Jun 2020

References

  • Acquah GE, Via BK, Fasina OO, Adhikari S, Billor N, Eckhardt LG. 2017. Chemometric modelling of thermogravimetric data for the compositional analysis of forest biomass. PLoS One. 12(3):e0172999.
  • Beisl S, Binder M, Varmuza K, Miltner A, Friedl A. 2018. UV-Vis spectroscopy and chemometrics for the monitoring of organosolv pretreatments. Chem Eng. 2(4):45.
  • Biancolillo A, Marini F. 2018. Chemometric methods for spectroscopy-based pharmaceutical analysis. Front Chem. 6:576.
  • Bu D. 2007. CAMO - Chemometric analysis for spectroscopy. https://www.yumpu.com/en/document/read/7708399/chemometric-analysis-for-spectroscopy-camo-software
  • Cook G, Cai C. 2018. Chapter 19 - Multivariate analysis and the pharmaceutical regulatory framework A2 - Ferreira, Ana Patricia. In: Menezes JC, Tobyn M, editors. Multivariate analysis in the pharmaceutical industry. Academic Press, London, United Kingdom; p. 421–434.
  • EMEA. 2014. Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for news submissions and variations. EMEA/CHMP/CVMP/QWP/17760/2009 Rev2 (27 January 2014).
  • Granato D, Putnik P, Kovacevic DB, Santos JS, Calado V, Rocha RS, Da Cruz AG, Jarvis B, Rodionova OY, Pomerantsev A. 2018. Trends in chemometrics: food authentication, microbiology, and effects of processing. Compr Rev Food Sci Food Saf. 17(3):663–677.
  • Jackson JE. 1991. A user’s guide to principal components. New York (NY): Wiley.
  • Kumar VP, Gupta NV. 2015. A review on quality by design approach (QBD) for pharmaceuticals. Int J Drug Dev Res. 7(1):52–60.
  • Li Y, Anderson CA, Drennen JK, Airiau C, Igne B. 2018. Method development and validation of an inline process analytical technology method for blend monitoring in the tablet feed frame using raman spectroscopy. Anal Chem. 90(14):8436–8444.
  • Long FH. 2019. Chapter 24: Multivariate analysis for pharmaceutical and medical device development. In: am Ende MT and am Ende DF, editors. Chemical engineering in the pharmaceutical industry: drug product design, development and modelling. New York: Wiley; p. 587.
  • Q10: Pharmaceutical Quality System. 2008. ICH tripartite guidelines. Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf.
  • Q2: Validation of Analytical Procedures. 1994. ICH harmonized tripartite guidelines. Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf.
  • Q8: Pharmaceutical Development. 2009. ICH harmonized tripartite guidelines. Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf.
  • Q9: Quality Risk Management. 2005. ICH harmonized tripartite guidelines. Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. https://database.ich.org/sites/default/files/Q9%20Guideline.pdf.
  • Shah D, He QP, Wang J. 2018. A spectroscopic chemometric modelling approach based on statistics pattern analysis. IFAC-PapersOnLine. 51(18):369–374.
  • Stagner WC, Haware RV. 2019. QbD innovation through advances in PAT, data analysis methodologies, and material characterization. AAPS PharmSciTech. 20(7):295.
  • Torres-Gamez J, Rodriguez JA, Paez-Hernandez ME, Galan-Vidal CA. 2019. Application of multivariate statistical analysis to simultaneous spectrophotometric enzymatic determination of glucose and cholesterol in serum samples. Int J Anal Chem. 2019:7532687.
  • Van de Sompel D, Garai E, Zavaleta C, Gambhir SS. 2012. A hybrid least squares and principal component analysis algorithm for Raman spectroscopy. PLoS One. 7(6):e38850.
  • Xiaobo Z, Jiewen Z, Povey MJW, Holmes M, Hanpin M. 2010. Variables selection methods in near-infrared spectroscopy. Anal Chim Acta. 667(1–2):14–32.
  • Zavaleta C, Smith B, Walton I, Doering W, Davis G, Shojaei B, Natan MJ, Gambhir SS. 2009. Multiplexed imaging of surface enhanced Raman scattering nanotags in living mice using noninvasive Raman spectroscopy. Proc Natl Acad Sci USA. 106 (32):13511–13516.

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