Development and Validation of HPTLC Method for Estimation of Tenofovir Disoproxil Fumarate in Tablet Dosage Form.

A simple, rapid, precise and accurate HPTLC method for the estimation of Tenofovir disoproxil fumarate was developed and validated. The chromatograms were developed using a mobile phase of ethyl acetate : methanol : formic acid(7:2.5:0.5 %v/v) on pre-coated plate of silica gel GF aluminum TLC plate and quantified by densitometric absorbance mode at 266 nm. The Rf value for Tenofovir disoproxil fumarate was 0.78. The linearity of the method was found to be within the concentration range of 125-750 ng/spot. The lower limits of detection and quantification were found to be 7.90 ng/spot and 23.93 ng/spot. The method was also validated for precision, specificity and recovery. This developed method was used to analyze fixed-dose tablet (TENOF, Genix Pharma).