DEVELOPMENT OF A RAPID AND EFFICIENT METHOD FOR QUANTITATIVE DETERMINATION OF N-NITROSODIMETHYLAMINE IMPURITY BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN METFORMIN HYDROCHLORIDE, LOSARTAN POTASSIUM, VALSARTAN AND RANITIDINE MEDICINAL RAW MATERIALS AND ITS PRODUCTS

Authors

  • Virab G. Kirakosyan Chair of Pharmaceutical Chemistry and Pharmacognosy, YSU, Armenia
  • Samvel M. Vardapetyan Chair of Pharmaceutical Chemistry and Pharmacognosy, YSU, Armenia
  • Lusine H. Varderesyan Scientific Centre of Drug and Medical Technology Expertise after academician E. Gabrielyan Armenia, Yerevan
  • Avetis H. Tsaturyan Chair of Pharmaceutical Chemistry and Pharmacognosy, YSU, Armenia

DOI:

https://doi.org/10.46991/PYSU:B/2021.55.3.296

Keywords:

NDMA, metformin hydrochloride, losartan potassium, valsartan, ranitidine

Abstract

In this study, chromatographic conditions were developed for the separation and quantification of N-nitrosodimethylamine (NDMA) by HPLC. Our method would be useful for the rapid screening and quantification of NDMA impurity in Metformin hydrochloride, Losartan potassium, Valsartan and Ranitidine drugs substance and its products. The chromatographic separation was achieved on a Phenomenex C18 column (250 mm, 5 µm, 4.6 mm) by multistep gradient elution, using a water-acetonitrile mobile phase containing 0.1% formic acid, which provided better c hromatographic separation. Column temperature was maintained at 30℃; mobile phase flow rate: 1 mL/min; wavelength: 254 nm; and injection volume of 20 μL.

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Published

2021-12-23

How to Cite

Kirakosyan, Virab G., Samvel M. Vardapetyan, Lusine H. Varderesyan, and Avetis H. Tsaturyan. 2021. “DEVELOPMENT OF A RAPID AND EFFICIENT METHOD FOR QUANTITATIVE DETERMINATION OF N-NITROSODIMETHYLAMINE IMPURITY BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN METFORMIN HYDROCHLORIDE, LOSARTAN POTASSIUM, VALSARTAN AND RANITIDINE MEDICINAL RAW MATERIALS AND ITS PRODUCTS”. Proceedings of the YSU B: Chemical and Biological Sciences 55 (3 (256):296-99. https://doi.org/10.46991/PYSU:B/2021.55.3.296.

Issue

Vol. 55 No. 3 (256) (2021)

Section

Short Communications

License

Copyright (c) 2021 Proceedings of the YSU

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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