Validated stability indicating assay method for tenofovir implementing design of experiment approach for forced degradation


Author(s): Vandana Gawande, Varsha Jadhav

Tenofovir, an antiretroviral drug known as nucleoside analogue reverse transcriptase inhibitor, was evaluated for its degradation behavior. The study involved optimization of forced degradation study using the design of experiment (DoE) approachand validation of developedstability indicating assay method (SIAM) for tenofovir. Chromatographic separation was achieved on Kromasil C18 column using mixture of methanol and ammonium acetate buffer pH 8.5 asmobilephasein isocratic elution mode. Detection was done using PDA detector. Tenofovirshoweddegradationatalkali, acid hydrolysisandoxidativeconditionwhileitwasstabletophotolysisandthermalstresscondition. Theoptimization of forceddegradationconditions,likehydrolyticandoxidative,wasdonebyapplication3nfullfactorialdesigns,whichhelpedtoobtaindesireddrugdegradation.The proposed method was successfully validated as per ICH Q2 (R1) guidelines.

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