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Analytical method development, validation, Synthesis, Characterization and Forced degradation study of Tenofovir Disoproxil Fumarate and its impurities

. Rinchi Bora , M R Jeyaprakash, Samrat Debnath , S. Jubie Department of Pharmaceutical Analysis, Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu, India


Tenofovir disoproxil fumarate (TDF) is a prodrug of antiretroviral class of drugs belonging to NRTIs. There are several simultaneous estimations reported for the drug tenofovir disoproxil fumarate (TDF) and different synthetic routes for synthesizing its impurity is also available. Due to cost effective method we chose to synthesize the impurity. To develop an analytical method for tenofovir disoproxil fumarate and one of its impurity. Synthesis and characterization of the impurity has to be performed. RP-HPLC with Shimpack C18 column (4.6 x 50 mm, i.d. 3µm) is used. A combination of methanol- acetonitrile (50:50) and ammonium acetate (pH 4.19) in the ratio of 50:50 V/V is used as the mobile phase. The flowrate is set at 1 mL/min. The absorbance was finalized using a UV-Vis spectrophotometer. LC-MS was used to obtain the mass spectra. IR was used for determining the functional group and NMR was used for the proton number. The absorbance was set at 260nm. From the analytical method development, LC showed drug peak at 6.103 and 8.621mins for the synthesized impurity. For the LC-MS, the impurity peak is seen at 1051.55. The developed method is found to be 98.85% accurate and precision obtained is 0.55%. It was found to be linear in the range of 10-60 µg/ml and passed Beer’s law with a correlation coefficient of 0.999. LOD and LOQ is found to be 0.514 and 1.713 µg/ml respectively. We can conclude from the performed experiment that a novel, simple and precise analytical method has been developed and validated for tenofovir disoproxil fumarate and for one of its impurity. Synthesis of the impurity has also been performed and then characterization of the same.


Index Terms- Tenofovir Disoproxil Fumarate, RP-HPLC, LC-MS, Acetonitrile, Impurities.

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