Method development and validation of tenofovir disoproxil fumerate and emtricitabine in combined tablet dosage form by UV-spectrophotometry and RP-HPLC

Abstract

A simple, accurate, rapid, precise and novel UV-Spectrophotometry and Reverse phase High Pressure liquid chromatographic
method (RP-HPLC) has been developed and validated for simultaneous determination of Tenofovir Disoproxil Fumerate(TDF)
And Emtricitabine(EMT) in combined tablet dosage form. At wavelength 260 nm both drugs have considerable absorbance.
The UV-Spectrophotometry method was found to be linear between the range of 5-25 μg/ml for TDF and 7-35 μg/ml for
EMT.The selected and optimized mobile phase was Acetonitrile : Phosphate pH 3.5 buffers in the ratio of 60:40 was fixed
due to good symmetrical peak. and conditions were flow rate (1.0 ml/minute), wavelength (270 nm), Run time was 5 min. The
retention time were found to be 2.85 min and 3.55 min for Tenofovir Disoproxil Fumerate And Emtricitabine respectively.
Linearity and range was found to be 3-15 µg/ml for Tenofovir Disoproxil Fumerate and 2-10 µg/ml for Emtricitabine. The
proposed chromatographic conditions were found appropriate for the quantitative determination of the drugs.The method was
validated for accuracy, precision, specificity, linearity, robustness, sensitivity, LOD and LOQ. The proposed method was
successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was
observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible.