Development and validation of the dissolution test method for a combination of lamivudine and zidovudine adapted to the requirements of the EAEU pharmacopoeia

Author:

Marakhova A. I., ,Kulikova A. M.,

Abstract

The dissolution test is intended to determine the amount of a medicinal substance, which should be released into the dissolution medium from a solid dosage form over a certain period of time under the conditions specified in the pharmacopoeial article for the drug. Developing the method indicated for the combination of antiretroviral drugs lamivudine and zidovudine in a dosage form is crucial as this will allow, along with the assessment of pharmaceutical equivalence, at least an approximate assessment of the bioequivalence of the drug/

Publisher

PANORAMA Publishing House

Subject

General Earth and Planetary Sciences,General Engineering,General Environmental Science,General Energy,General Medicine,General Medicine,General Materials Science,General Medicine,General Medicine,General Medicine,General Medicine,Anesthesiology and Pain Medicine

Reference11 articles.

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2. 2. Gonchikova, Iu. A. Sovershenstvovanie metodov analiza antiretrovirusnykh lekarstvennykh sredstv [Improving methods for the analysis of antiretroviral drugs]: thesis for the degree of PhD Candidate in Pharmacy: 14.04.02 / Iuliya Anatolievna Gonchikova; - Irkutsk, 2018- 188 p. (In Russ.)

3. 3. GOST ISO/IEC 17000-2012. Bibliographic record. Interstate standard Conformity assessment. Vocabulary and General Principles (2013). - Moscow: Standartinform, 2013. - 24 p. - (System of standards for information, librarianship and publishing). (In Russ.)

4. 4. State Pharmacopoeia XIV edition: State Pharmacopoeia of the Russian Federation XIV ed. Volume 1. OFS.1.1.0012.15 «Validation of analytical methods». - P. 276-288. (In Russ.)

5. 5. State Pharmacopoeia of the Russian Federation XIV ed. Volume 1. OFS.1.1.0013.15 «Statistical processing of the results of a chemical experiment». (In Russ.)

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