RESEARCH BY HPLC METHOD THE QUANTITATIVE CONTENT AND RELATED IMPURITIES OF PROTHIONAMIDE
DOI:
https://doi.org/10.11603/2312-0967.2016.4.7115Keywords:
prothionamide, tablets, quality control, tuberculosis, HPLC, quantitative determination, related impurities.Abstract
Introduction
InUkrainethe number of infected citizens began to increase in 1991, and officially recorded epidemic of tuberculosis registered from 1995. Among european countries, our country occupies second place in the incidence of tuberculosis.
It is therefore extremely important is the effective treatment of this disease, which is carried out with the use of drugs first (isoniazid, rifampicin, pyrazinamide, ethambutol, streptomycin) and second series (ethionamidum, protionamid, kanamycin, amikacin, ciprofloxacin, ofloxacin, cycloserine, capreomycin, rifabutin, para-aminosalicylic acid, thiacetazone)
Protionamid is anti-tuberculosis second line drug, which inhibits the synthesis of peptides and mycolic acids and exhibits bacteriostatic effect.
The goal of this work is quantitative determination of the active pharmaceutical ingredient (API) and its related substances in some prothionamide tablets.
Materials and methods
The study was performed on Agilent 1200 chromatograph with spectrophotometric detector by reversed-phase HPLC in isocratic mode detection in the UV spectrum.
The column Zorbax CB-C18 (length150 mm, diameter4.6 mm,3 mmgrain) used, column temperature25 °C, mobile phase velocity of 0.5 ml/min, λ = 290 nm, injection volume 20 ml, mobile phase - phosphate buffer : acetonitrile.
Quantitative determination of the API was made by using the external standard method. A dilute solution of the API was used to determine the amount of impurities.
Results and discussion
The results of chromatographic studies are in the three tables, chromatogram of the protionamid test solution provided on the picture.
It is shown that the medical product complys with spesified parameters of the normative documents: it contains 99,7% of the declared quantity and the total identified and not identified impurities ≤ 0,54%.
Conclusions
1. Using the proposed scheme enables research to quantify the active pharmaceutical ingredient and impurities in tablets protionamid. The method provides high accuracy, reproducibility and selectivity analysis.
2. Check protionamid drug tablets on quantitative content of active ingredient and associated contaminants by HPLC showed that the drug meets requirements of regulatory documents and is safe for consumers.
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