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Pharmaceutical Chemistry Journal

, Volume 53, Issue 10, pp 986–990 | Cite as

Validation of a Method for Assay of Excipients in Liposomal Medicinal Formulations of the Photosensitizer Lipophthalocyan

  • A. V. Lantsova
  • Yu. V. Olefir
  • N. D. BunyatyanEmail author
  • E. V. Sanarova
  • O. L. Orlova
  • M. V. Dmitrieva
  • A. P. Polozkova
  • N. A. Oborotova
  • M. A. Ogai
  • Z. D. Khadzhieva
  • L. L. Nikolaeva
  • D. V. Kompantsev
  • A. M. Shevchenko
  • A. B. Prokof’ev
STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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An assay method for the excipients (sucrose, phosphatidylcholine, and cholesterol) of liposomal medicinal formulations of the phthalocyanine photosensitizer lipophthalocyan by TLC with chromatodensitometry was validated. Coefficients of standard residual deviation for establishment of linearity were 3.48 for sucrose, 1.69 for phosphatidylcholine, and 1.36 for cholesterol. The coefficients of variation for determination of similarity and intermediate precision were less than 5%. The method was shown to be reliable over a wide range of conditions for the suitability of the system.

Keywords

Excipients assay validation TLC with chromatodensitometry 

References

  1. 1.
    N. D. Bunyatyan, N. A. Oborotova, L. L. Nikolaeva, et al., Pharm. Chem. J., 52(9), 799 – 802 (2018).CrossRefGoogle Scholar
  2. 2.
    G. A. Meerovich, L. M. Borisova, A. P. Bud’ko, et al., Ros. Bioter. Zh.,16(4), 74 – 79 (2017).Google Scholar
  3. 3.
    A. P. Bud’ko, Z. G. Deichman, G. A. Meerovich, et al., Biomedical Photonics, 7(4), 16 – 22 (2018).CrossRefGoogle Scholar
  4. 4.
    Validation of Analytical Procedures: Text and Methodology Q2 (R1), ICH Harmonised Tripartite Guideline, 2005 (2005).Google Scholar
  5. 5.
    Zh. I. Aladysheva, V. V. Belyaev, and V. V. Beregovykh, Farmatsiya, 7, 21 – 24 (2008).Google Scholar
  6. 6.
    V. V. Beregovykh, Zh. I. Aladysheva, and I. A. Samylina, Farmatsiya, 3, 10 – 12 (2008).Google Scholar
  7. 7.
    E. V. Sanarova, A. P. Polozkova, I. G. Meerovich, et al., Pharm. Chem. J., 46(6), 386 – 388 (2012).CrossRefGoogle Scholar
  8. 8.
    General Pharmacopeia Monograph OFS. 1.1.0013.15, Statistical Processing of Experimental Results [in Russian].Google Scholar
  9. 9.
    C. B. Roces, E. Kastner, P. Stone, D. Lowry, and Y. Perrie, Pharmaceutics, 8(3), 29 (2016).CrossRefGoogle Scholar
  10. 10.
    E. J. Lesnefsky, M. S. Stoll, P. E. Minkler, and C. L. Hoppel, Anal. Biochem., 285(2), 246 – 254 (2000).CrossRefGoogle Scholar
  11. 11.
    S. Hatziantoniou and C. Demetzos, Methods Mol. Biol.606, 363 – 368 (2010).CrossRefGoogle Scholar
  12. 12.
    A. Laouini, C. Jaafar-Maalej, I. Limayem-Blouza, et al., J. Colloid Sci. Biotechnol., 1, 147 – 168 (2012).CrossRefGoogle Scholar
  13. 13.
    D. Jeschek, G. Lhota, J.Wallner, and K. Vorauer-Uhl, J. Pharm. Biomed. Anal., 119, 37 – 44 (2016).CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2020

Authors and Affiliations

  • A. V. Lantsova
    • 1
  • Yu. V. Olefir
    • 2
    • 3
  • N. D. Bunyatyan
    • 2
    • 3
    Email author
  • E. V. Sanarova
    • 1
  • O. L. Orlova
    • 1
  • M. V. Dmitrieva
    • 1
  • A. P. Polozkova
    • 1
  • N. A. Oborotova
    • 1
  • M. A. Ogai
    • 4
  • Z. D. Khadzhieva
    • 4
  • L. L. Nikolaeva
    • 1
    • 2
  • D. V. Kompantsev
    • 4
  • A. M. Shevchenko
    • 4
  • A. B. Prokof’ev
    • 2
    • 3
  1. 1.N. N. Brokhin State Science Research Center of OncologyMinistry of Health of the Russian FederationMoscowRussia
  2. 2.I. M. Sechenov First Moscow Medical InstituteMinistry of Health of the Russian Federation (Sechenov University)MoscowRussia
  3. 3.Scientific Center for Expert Assessment of MedicinesMinistry of Health of the Russian FederationMoscowRussia
  4. 4.Pyatigorsk Medical-Pharmaceutical Institute (a branch of Volgograd State Medical University)Ministry of Health of the Russian FederationPyatigorskRussia

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