Validated RP-HPLC Method Development for Estimation of Tenofovir Disoproxil Fumarate from Plasma

Tenofovir Disoproxil Fumarate, a diester prodrug of Tenofovir, is a nucleotide reverse transcriptase inhibitor. After oral absorption, Tenofovir Disoproxil Fumarate is rapidly converted to tenofovir and then undergoes subsequent phosphorylation by cellular enzymes to the active Tenofovir Diphosphate, which inhibits the activity of HIV-1 reverse transcriptase. There are very few methods for analysis of degradation products and impurities of Tenofovir Disoproxil Fumarate have been reported. The present work based on development of suitable, specific and sensitive analytical method. Here we have developed a precise, accurate, simple, reliable and less time consuming RP-HPLC method for estimation of this drug from plasma. The result for precision was R.S.D. ≤ 20% at LLOQ and R.S.D. ≤ 15% other than LLOQ. This shows that the method is accurate and precise. Result of short term stability study performed by thawing samples at low and high concentration for 6 hours and % stability calculated which is between 85–115%. Extraction recovery was determined by spiking the pure drug sample in previously analyzed sample which is more than 50%.