The development of HPLC determination of aciclovir’s fragment in new pharmaceutical substance acyclogermanium

  • Sergey V. Aleshin the postgraduate student I.M. Sechenov First Moscow State Medical University, Research Institute of Pharmacy, Moscow, e-mail neos.1991@gmail.com
  • Igor V. Ambrosov Ph.D., «WDS Pharma» LLC, Moscow (resident of Skolkovo Innovation Center), R&D of new organic germanium compounds, Moscow, email: igor.ambrosov@wdspharma.ru
  • Svetlana K. Matelo «WDS Pharma» LLC, Moscow (resident of Skolkovo Innovation Center), R&D of new organic germanium compounds, Moscow
  • Igor E. Shohin Ph.D., -head of pharmacokinetics and dosage form laboratory, Scientific center for biomedical technologies FMBA, Svetlye gory
Keywords: high performance liquid chromatography, acyclovir, acyclogermanium, organic germanium.

Abstract

The objects of the study was new active pharmaceutical ingredient acyclogermanium
(Ge2[C6H5O7]4[C8H11N5O3][C6H14N4O2]), organometallic germanium compound with aciclovir’s fragment. A
simple, rapid, and selective HPLC method was developed for the estimation of acyclovir’s fragment in
pharmaceutical substance and dosage form (water-soluble gel). The chromatographic behavior of the
aciclovir was studied by HPLC on a reverse phase C18 column with spectrophotometric detection with
recourse to eluent phosphate buffer (pH 2.5) – acetonitrile, 96:4, at a flow rate of 1.0 mL/min with UV
detection at 254±4 nm. The retention time of acyclovir was 3.5 minutes. The purity of the compound was
also studied. The main impurity is detected and identified as guanine by UV-spectrophotometry and massspectrometry
.

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References

1.Amchenkova A.M. et al., Sb. nauch. Trudov «Interferon–89», M., 1989, pp. 35-37.
2.Isaev A.D. et al., Patent RU № 2475436, 2013 (PCT WO2013/112072), Patentee & Applicant «WDS Pharma LLC».
3.Isaev A.D. et al., Patent RU № 2487878, 2013, (PCT WO2013/172732), Patentee & Applicant «WDS Pharma LLC».
4.Gosudarstvennyi reestr sredstv izmerenii. URL: http://www.fundmetrology.ru/10_tipy_si/7list.as px (data obrashcheniya 22.02.2015).
5.“European Pharmacopoeia 7.0”, Council of Europe. European Directorate for the Quality of Medicines and HealthCare (EDQM), 2011.
6.Mironov A.N. et al., Rukovodstvo po ekspertize lekarstvennykh sredstv, M, Grif i Ko, 2013, Vol. 2, 280 p.
7.Rukovodstvo po instrumental'nym metodam issledovaniya pri razrabotke i ekspertize kachestva lekarstvennykh preparatov, pod red. S.N. Bykovskogo et al., M., Pero, 2014, pp. 80-118.
8.Karasek F., Klement R., Vvedenie v khromato-mass-spektrometriyu, M., Mir, 1993, 235 p.
9.Gregson J., Mass spectrometry of nucleosides related to guanosine, and codicillary research topics, Diss., Utah, 1994., pp. 30-45.
Published
2019-11-14
How to Cite
Aleshin, S. V., Ambrosov, I. V., Matelo, S. K., & Shohin, I. E. (2019). The development of HPLC determination of aciclovir’s fragment in new pharmaceutical substance acyclogermanium. Sorbtsionnye I Khromatograficheskie Protsessy, 16(1), 93-99. Retrieved from https://journals.vsu.ru/sorpchrom/article/view/1329