Standardization of medicinal drug with original substance of benzophenone derivative for HIV-1 infection treatment


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Abstract

Synthetic pyrimidine derivative of benzophenone l-[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 gualitative and guantitative 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 guantify the active substance in the drug high-performance liguid chromatography with UV detection was proposed, acceptance criteria for guality control were established, methods were validated according to modern reguirements and met them in all parameters. To assess the tablets guality 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 benzophenone derivative for treatment of HIV-1 infection were proposed and validated.

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About the authors

V. M Kosman

St.-Petersburg Institute of Pharmacy

Email: kosmanvm@doclinika.ru
Ph.D. (Pharm.) Russian Federation, Leningrad region, Vsevolozhski municipal district, Kuzmolovo

E. A Jain (Korsakova)

Lomonosov Moscow State University

Post-graduate Student Russian Federation, Moscow

D. V Demchenko

St.-Petersburg Institute of Pharmacy

Ph.D. (Pharm.) Russian Federation, Leningrad region, Vsevolozhski municipal district, Kuzmolovo

V. G Makarov

RMC "HOME OF PHARMACY"

Email: info@doclinika.ru
Dr.Sc. (Med.), Professor Russian Federation, Leningrad region, Vsevolozhski municipal district, Kuzmolovo

V. Y Balabanyan

Lomonosov Moscow State University

Dr.Sc. (Pharm.) Russian Federation, Moscow

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