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

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/