Development and Validation of Analytical Methods for Anti Viral Drugs

Abstract

Many people died every year due to HIV/AIDS. HIV is a human immune virus which attacks on newlineimmune system of the body and lowers the defence system of our body and lead to major complications which leads to death. WHO and USFDA has recommended a use of Anti- etroviral medicines to reduce viral infections. Based on literature review, two different fixed dose combinations have been selected for research work. First fixed dose combination contains Lamivudine, Tenofovir disoproxil fumarate and Efavirenz tablets. Second fixed dose combination contains Emtricitabine and Tenofovir disoproxil newlinefumarate tablets. Analytical methods for Lamivudine, Tenofovir disoproxil fumarate and Efavirenz fixed dose tablet formulation. newlineThis fixed dose tablet formulation is official in Indian pharmacopeia. Based on literature review of available analytical methods of this combination, total 4 analytical methods have been developed and newlinevalidated. To calculate % of drug dissolved, simple, rapid method for dissolution testing by HPLC have been developed having a short run time of 13 minutes. BCS solubility was performed for all three actives and from results of solubility study, dissolution media selected. Dissolution parameters selected from the guidance for industry document. Developed analytical method have been validated as per ICH and USP guideline. To improve efficiency and reduce analysis time, sensitive and rapid UPLC method have also been developed and validated for dissolution testing of this fixed dose combination. To avoid use of highly corrosive materials and to reduce cost per analysis, stability indicating assay newlinemethod by HPLC was developed and validated as per ICH and USP. Degradation products were generated in different stress conditions and known impurity standards were injected to confirm the identity of that degradation product. So proposed method was found to be simple, specific and stability indicating. To estimate impurities of all three actives, stability indicating Related substances method was developed.