DEVELOPMENT OF METHODS CHARACTERIZATION AND IDENTIFICATION OF EFAVIRENZ IN THE MIXTURES AND COMPOSITIONS WITH EXCIPIENTS BY THE METHOD OF FTIR-SPECTROSCOPY

DOI: https://doi.org/10.29296/25877313-2020-01-02
Issue: 
1
Year: 
2020

V.L. Beloborodov Dr.Sc. (Pharm.), Рrofessor, Department of Chemistry, Institute of Pharmacy, Sechenov First Moscow State Medical University E-mail: vlbe@list.ru N.B. Demina Dr.Sc. (Pharm.), Рrofessor, Department of Pharmaceutical Technology Institute of Pharmacy, Sechenov First Moscow State Medical University E-mail: nbd217@mail.ru E.O. Bakhrushina Ph.D. (Pharm.), Associate Professor, Department of Pharmaceutical Technology, Institute of Pharmacy, Sechenov First Moscow State Medical University E-mail: bachrauschenh@mail.ru S.A. Zolotov Director for the Production and Development of Drugs and Active Pharmaceutical Substances, LLC «AMEDART» (Moscow) E-mail: duim50@gmail.com A.S. Zolotova Ph.D. (Pharm.), Head of the Laboratory of Drug Technology, LLC «Farm-Sintez Lab» (Moscow) E-mail: max_in_a@mail.ru I.I. Krasnyuk Dr.Sc. (Pharm.), Professor, Head of Department of Pharmaceutical Technology, Institute of Pharmacy, Sechenov First Moscow State Medical University E-mail: krasnyuki@mail.ru

Efavirenz (EFV) is an antiretroviral drug used to treat type 1 immunodeficiency virus infections. In order to increase bioavailability, solid EFV formula-tions with different carriers are being developed. Purpose of the study - evaluation of the possibility of applying the IR spectroscopy method to charac-terize the authenticity of mechanical EFV mixtures and compositions with Neusilin® US2, Kollidon®VA 64, Soluplus® and Eudragit® EPO. Evaluated the possibility of applying the method of FTIR-spectroscopy for the characterization of the authenticity of the mechanical mixtures and compositions EFV with Neusilin, Kollidon, Soluplus and Eudragit. In the Attenuated Total Reflection IR-ATR-spectra, after subtraction of the excipients, it is possible to iden-tify EFV by characteristic absorption bands corresponding to stretching vibrations of N-H, C≡C, C=O, CAr–CAr and C–F bonds. Analysis of the spectra of EFV mixtures with carriers indicates the absence of structural changes at the molecular level as a result of joint processing. The application of the IR-spectroscopy ATRs technique for EFV identification in compositions and mixtures with the above carriers is informative and does not require complex sample preparation, which makes it possible to recommend it as a pharmacopoeial indicator of the «compliance» of the developed dosage forms.

Keywords: 
efavirenz
neusilin
kollidon
soluplus
eudragit. IR-spectroscopy

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