Lamivudine and zidovudine belong to the class of nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral drugs, which are in the National List of Essential Medicines for the treatment of HIV infection. However, their qualities have not yet been surveyed. Thus, for the fiscal year 2018, Bureau of Drug and Narcotic conducted a drug quality assurance program on the fixed-dose combination products of lamivudine and zidovudine. A total of 10 samples from one local manufacturer and one importer were evaluated using a verified method according to USP 40. Tests for identification, assay, weight variation, content uniformity, organic impurities and dissolution were performed. The results showed that all products complied with every requirement. It can be concluded that quality of the lamivudine and zidovudine tablets was optimal.
Keyword : lamivudine and zidovudine tablets, quality