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STANDARDIZATION OF MEDICINAL DRUG WITH ORIGINAL SUBSTANCE OF BENZOPHENONE DERIVATIVE FOR HIV-1 INFECTION TREATMENT

DOI: https://doi.org/10.29296/25877313-2021-01-01
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Issue: 
1
Year: 
2021

V.M. Kosman Ph.D. (Pharm.), St.-Petersburg Institute of Pharmacy (Russian Federation, Leningrad region, Vsevolozhski municipal district, Kuzmolovo) E-mail: kosmanvm@ doclinika.ru E.A. Jain (Korsakova) Post-graduate Student, Lomonosov Moscow State University, Faculty of Medicine (Russian Federation, Moscow) D.V. Demchenko Ph.D. (Pharm.), St.-Petersburg Institute of Pharmacy (Russian Federation, Leningrad region, Vsevolozhski municipal district, Kuzmolovo) V.G. Makarov Dr.Sc. (Med.), Professor, RMC “HOME OF PHARMACY” (Russian Federation, Leningrad region, Vsevolozhski municipal district, Kuzmolovo) E-mail: info@doclinika.ru V.Y. Balabanyan Dr.Sc. (Pharm.), Lomonosov Moscow State University, Faculty of Medicine (Russian Federation, Moscow)

Synthetic pyrimidine derivative of benzophenone 1-[2-(2-benzoylphenoxy)ethyl]-6-methyluracil was proposed as an original pharmaceutical substance for the development of antiretroviral drugs. The aim of the study was to develop and validate methods for qualitative and quantitative standardization of the drug dosage form (tablets) with the original pharmaceutical substance of the benzophenone derivative for the treatment of HIV-1 infection. Material and methods. Experimental tablets were obtained in laboratory conditions of RMC “HOME OF PHARMACY” (Russia) in accordance with laboratory guidelines and analyzed by various pharmacopoeia methods. Results. In order to evaluate the identification and quantify the active substance in the drug high-performance liquid chromatography with UV detection was proposed, acceptance criteria for quality control were established, methods were validated according to modern requirements and met them in all parameters. To assess the tablets quality tests on the characteristics of appearance, average weight and uniformity in weight, abrasion, disintegration, excipients (aerosil) were proposed. Conclusion. Methods of standardization based on HPLC with UV-detection for dosage form with original pharmaceutical substance based on benzophe-none derivative for treatment of HIV-1 infection were proposed and validated.

Keywords: 
tablets
original substance
benzophenone derivative
standardization

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