Abstract
HIV infection poses a threat to the existence of humankind as a whole. Currently, lamivudine is widely used in antiretroviral therapy regimens. Modern methods of assessing quality, both in substance and in tablets, are characterized by a number of shortcomings: high cost of equipment, expensive GSO production of the United States. The development of new methods for the analysis of lamivudine, as well as the improvement of existing methods, is an urgent problem. The purpose of this study is to develop a new technique for the quantitative determination of lamivudine by UV spectrophotometric method using a standard sample. The absorption spectrum of lamivudine solutions was studied at different pH values (1.1-14.1) in the wavelength range 200-400 nm. The optimal solvent for the spectrophotometric determination of the test substance was 0.1M HCl (pH 1.1). At pH 1.1, two absorption bands with absorption maxima at wavelengths of 212 ± 1 nm and 279 ± 1 nm are observed in the absorption spectrum of the lamivudine solution. A substance of organic nature, 4,4'-dihydroxyphthalophenone, was chosen as the standard sample for the determination of lamivudine. The maximum absorption of lamivudine (279 nm) is included in the optimal range for 4,4'-dihydroxy-phthalophenone (268-282 nm). The conversion ratio of lamivudine for 4,4'-dihydroxyphthalophenone is 0.1985. The error in determining lamivudine in the substance does not exceed 0.85 %, in tablets -1.6 %. The validation assessment confirmed the compliance of the developed methodology with normative documents and its suitability for analysis.
Highlights
HIV infection poses a threat to the existence of humankind as a whole
Lamivudine is widely used in antiretroviral therapy regimens
The purpose of this study is to develop a new technique for the quantitative determination of lamivudine by UV spectrophotometric method using a standard sample
Summary
HIV infection poses a threat to the existence of humankind as a whole. Currently, lamivudine is widely used in antiretroviral therapy regimens. The development of new methods for the analysis of lamivudine, as well as the improvement of existing methods, is an urgent problem. The purpose of this study is to develop a new technique for the quantitative determination of lamivudine by UV spectrophotometric method using a standard sample. The absorption spectrum of lamivudine solutions was studied at different pH values ( 1.1–14.1) in the wavelength range 200–400 nm. The optimal solvent for the spectrophotometric determination of the test substance was 0.1M HCl (pH 1.1). A substance of organic nature, 4,4’-dihydroxyphthalophenone, was chosen as the standard sample for the determination of lamivudine. The maximum absorption of lamivudine (279 nm) is included in the optimal range for 4,4’-dihydroxyphthalophenone (268–282 nm). The error in determining lamivudine in the substance does not exceed 0.85 %, in tablets – 1.6 %.
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