Determination of tenofovir disoproxil fumarate in pharmaceutical preparations by UPLC

An ultra performance liquid chromatograhic method was developed for the determination of Tenofovir disoproxil fumarate related substances in pharmaceutical formulation. The validation of the developed method has been successfully completed. Chromatographic separations were performed by gradient elution with C18 column using mobile phase A: pH 4,6 acetate buffer and: mobile phase B: Acetonitrile using 0,2 mL/min flow rate. It was carried out at 260 nm wavelength using PDA and UV detector. The linear range is between 0,13– 51 µg/mL. The limit of quantification were found as 0,045 µg/mL and 0,99 µg/mL, respectively. Accuracy studies were carried out between LOQ level, 100%, 120% and 240%. This developed method has also been successfully applied to drug substance and its impurities in the pharmeceutical formulation and the analysis of the degradation products formed as a result of the stress study.