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DEVELOPMENT OF APPROACHES TO THE ANALYSIS OF ELEMENTAL IMPURITIES IN TITANIUM DIOXIDE (BARIUM AND LEAD DEFINITION)

DOI: https://doi.org/10.29296/25877313-2024-01-04
Issue: 
1
Year: 
2024

I.V. Paskar
Ph.D. (Pharm.), Managing Director,
LLC Test Centre «FARMOBORONA» (Korolev, Russia)
E-mail: paskar_irina@farmoborona.ru
S.P. Senchenko
Dr.Sc. (Pharm.), Associate Professor, Head of Department of Analytical Methods Development,
LLC Test Centre «FARMOBORONA» (Korolev, Russia)
E-mail: senchenko_sergey@farmoborona.ru
O.A. Kapiturova
Head of the Analytical Laboratory,
LLC Test Centre «FARMOBORONA» (Korolev, Russia)
E-mail: kapiturova_olga@farmoborona.ru
E.V. Borkovskaya
Ph.D. (Chem.), Chemist of Department of Analytical Methods Development,
LLC Test Centre «FARMOBORONA» (Korolev, Russia)
E-mail: borkovskaya_evgeniya@farmoborona.ru
N.G. Paskar
Student,
I.M. Sechenov First Moscow State Medical University (Sechenov University)
of Ministry of Health of the Russian Federation (Moscow, Russia)

Relevance. Titanium dioxide (TiO2) is widely used in the pharmaceutical industry as a drug excipient (DE). Therefore, control of its content of ele-mental impurities (EI) plays an important role in ensuring the stability of quality and safety of drugs. The lack of harmonized pharmacopoeial require-ments for the content of EIs in TiO2, as well as the need for specialized validated methods of their analysis determine the actual task in the field of quality control of this substance. Research objective. This work is devoted to the development and validation of a method for the determination of barium and lead in TiO2 sub-stance. Material and Methods. The inductively coupled plasma atomic emission spectrometry (ICP-AES) method was used to determine the barium and lead content in the TiO2 substance. Acid extraction was used in the sample preparation process. All used reagents and materials were in accordance with pharmacopoeial requirements. A sample of TiO2 substance, manufactured by Venator Germany GmbH, Germany, was used as an object of study. Validation of the method was carried out in accordance with the requirements of GF RF for the following characteristics: specificity, linearity, LOQ, correctness, repeatability, intra-laboratory precision and range of the technique. Results. The method of barium and lead determination in TiO2 substance using ICP-AES demonstrates high accuracy and sensitivity. The results ob-tained during validation meet the acceptance criteria, which confirms the applicability of the technique for control of barium and lead content in TiO2 substance. Conclusions. A method for the determination of barium and lead impurities in TiO2 substance using the ICP-AES method and acid extraction during sample preparation has been developed. This approach enables the determination of barium and lead at the specification level (20 ppm and 5 ppm, re-spectively). The validation results meet the acceptance criteria for all characteristics investigated, confirming the ability to quantify barium and lead in the range of 50% to 150% of the specification level.
Keywords: 
titanium dioxide
elemental impurities
ICP-AES
validation.
References: 
  1. Paskar' I.V., Senchenko S.P., Kapiturova O.A., Bor-kovskaja E.V., Troshin V.A., Paskar' N.G. Razrabotka podhodov k analizu jelementnyh primesej v substancii titana dioksida (opredelenie mysh'jaka). Voprosy biologicheskoj, medicinskoj i farmacevticheskoj himii. 2023; 26(11): 1926.
  2. Paskar' I.V., Senchenko S.P., Kapiturova O.A., Borkovskaja E.V., Troshin V.A., Paskar' N.G. Razrabotka podhodov k analizu jelementnyh primesej v substancii titana dioksida (opredelenie sur'my). Voprosy biologicheskoj, medicinskoj i farmacevticheskoj himii, 2023; (12): 3239.
  3. Racovita A.D. Titanium Dioxide: Structure, Impact, and Toxicity. Int J Environ Res Public Health. 2022 May 6; 19(9): 5681.
  4. Blundell R., Butterworth P., Charlier A., et al. The Role of Titanium Dioxide (E171) and the Requirements for Replacement Materials in Oral Solid Dosage Forms: An IQ Consortium Working Group Review. J Pharm Sci. 2022; 111(11): 2943‒2954.
  5. Vazhnaja rol' titana dioksid v farmacevtike. https://www.tdma.info/uses-of-titanium-dioxide/the-essential-role-of-titanium-dioxide-in-pharmaceuticals/.
  6. EP 10.5 «TITANIUM DIOXIDE» (07/2021:0150).
  7. EP 11.2 «TITANIUM DIOXIDE» (07/2023:0150).
  8. USP–NF 2022 «Titanium Dioxide».
  9. BP 2020 «Titanium Dioxide» (11-1154, V-A152).
  10. JP XVII Titanium Oxide.
  11. EP 10.8. 2.4.20 «DETERMINATION OF ELEMENTAL IMPURITIES» (07/2018:20420 corrected 9.6).
  12. GF RF FS.2.2.0017.15 «Tal'k».
  13. Huang, Chaozhang, Bin Hu, Zu-cheng Jiang. Simultaneous speciation of inorganic arsenic and antimony in natural waters by dimercaptosuccinic acid modified mesoporous titanium dioxide micro-column on-line separation and inductively coupled plasma optical emission spectrometry determination. Spectrochimica Acta Part B: Atomic Spectroscopy. 2007; 62: 454‒460.
  14. Xiao Y., Ling J., Qian S., et al. Preconcentration of trace arsenite and arsenate with titanium dioxide nanoparticles and subsequent determination by silver diethyldithiocarbamate spectrophotometric method. Water Environ Res. 2007 Sep; 79(9): 1015‒22.
  15. Hagarová, Ingrid, Peter Matúš, Marek Bujdoš, Jana Kubová. Analytical application of nano-sized titanium dioxide for the determination of trace inorganic antimony in natural waters. Acta chimica Slovenica 2012; 59(1): 102‒108.
  16. GF RF OFS.1.1.0012.15 «Validacija analiticheskih metodik».