The study of the quantitative content, gastro-resistance and related impurities in pantoprazole tablets

N. A. Savina, O. M. Kuznetsova, V. V. Bryazkalo, V. M. Britsun, N. V. Ostanina

Abstract


The quality control of pantoprazole tablets of foreign manufacture has been carried out by the method of reversephase HPLC. The quantitative determination, the assessment of gastro-resistance and the content of related impurities have been conducted. The test results are summarized in five Tables, and the chromatogram of pantoprazole test solution is shown in Fig. The quantitative determination of the active substance was performed by the external standard method. It has been found that the content of the substance in the medicine is 40.2 mg (100.5%), i.e. within the normal range. The gastro-resistance study demonstrated that after treating with decimolar solution of hydrochloric acid 0.4% of pantoprazole was dissolved. Thus, the medicine complies with the manufacturer’s specifications. Determination of related impurities was performed using the method of the reference solution (with the known concentration of the impurity for identified impurities) and comparing with a dilute solution of the active substance (for unidentified impurities). The solution for the system suitability test (containing pantoprazole and impurities – sulphone and sulphide), reference solutions (with the pantoprazole concentration of 0.1% and 1.0% of the test solution, respectively) and the test solution were prepared to determine the amount of impurities. Our studies have shown that pantoprazole tablets contain 0.17% of the identified and 0.10% of the unidentified impurities (the total content of all impurities is up to 0.27%). Thus, the pantoprazole parameters tested correspond to the regulatory requirements, and this medicine is safe for consumers.


Keywords


pantoprazole; tablets; HPLC; quantitative determination; gastro-resistance; related impurities; quality control

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DOI: https://doi.org/10.24959/ophcj.16.899

Abbreviated key title: Ž. org. farm. hìm.

ISSN 2518-1548 (Online), ISSN 2308-8303 (Print)