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

Abstract

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.