Determination of related impurities in glimepiride tablets by the HPLC method

Authors

  • N. O. Savina State Institution “O. M. Marzeyev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”, Ukraine
  • N. M. Ocherethyana State Institution “O. M. Marzeyev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”, Ukraine
  • V. M. Britsun State Institution “O. M. Marzeyev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”, Ukraine
  • N. V. Ostanina State Institution “O. M. Marzeyev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”, Ukraine

DOI:

https://doi.org/10.24959/nphj.17.2141

Keywords:

glimepiride, tablets, quality control, diabetes mellitus type 2, HPLC, related impurities

Abstract

Glimepiride is one of the modern and effective drugs that counteract diabetes mellitus type 2. Like other drugs glimepiride must comply with quality standards set by relevant government departments.

Aim. To determine the content of related impurities in glimepiride tablets in order to assess the drug quality.

Materials and methods. The study was performed by the reversed-phase HPLC with a spectrophotometric detector in the isocratic mode, in the UV-region of the spectrum. To determine impurities the method of comparison with the solution having the known concentration of impurities and the active substance was used.

Results and discussion. It has been shown that the drug contains ≤ 0.18 % of identified and unidentified impurities.

Conclusions. The purity of the drug complies with the requirements of normative documents.

Author Biographies

N. O. Savina, State Institution “O. M. Marzeyev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”

researcher of the State Research Laboratory for Quality Control of Medicines

N. M. Ocherethyana, State Institution “O. M. Marzeyev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”

researcher of the State Research Laboratory for Quality Control of Medicines

V. M. Britsun, State Institution “O. M. Marzeyev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”

Doctor of Chemistry (Dr. habil.), chief researcher of the State Research Laboratory for Quality Control of Medicines

N. V. Ostanina, State Institution “O. M. Marzeyev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”

Candidate of Economics (Ph.D.), researcher, head of the State Research Laboratory for Quality Control of Medicines

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Published

2017-06-16

Issue

No. 2(90) (2017)

Section

Synthesis and Analysis of Biologically Active Substances

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