Lamivudine belongs to the class of nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral drugs for the treatment of HIV and hepatitis B infection. Lamivudine was included in the antiretroviral regimen recommended by WHO Guideline 2003; however, its quality has not yet been surveyed. In the fiscal year 2018, pharmaceutical quality of the lamivudine tablets were evaluated by the Bureau of Drug and Narcotic. Twenty-three samples were randomly collected from the public hospitals and the manufacturers. The samples consisted of three strengths of 100, 150 and 300 mg tablet with 5 registration numbers. They were produced from one local manufacturer and imported from two companies. The verified analytical methods as per the USP 40 including identification, assay, weight variation, organic impurities and dissolution were performed. The results showed that all tested samples met the acceptance criteria. Thus, it indicated that lamivudine tablets prescribed in Thailand possessed the satisfactory pharmaceutical characteristics.
Keywords: Lamivudine tablets, quality