Process evaluation for simultaneous determination of Zidovudine and Lamivudine on the nanocarrier dendrimer by HPLC-PDA method.

Abstract

o determine Zidovudine (AZT) and Lamivudine (3TC) at the same time based on PAMAM dendrimer modified with Pluronic F127, application as anti-HIV drug control. A fast, accurate HPLC-PDA determination of AZT and 3TC with high reliability and selectivity has been developed and validated according to ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines. The chromatography was carried out by C18 inversion column using the mobile phase of phosphate buffer solution of pH 2.5 - methanol (65:35), flow rate 1.0 ml/min, and detective wavelength 266 nm. The retention times of AZT and 3TC are 3.5 and 4.3 minutes, respectively with 3.15 resolution. Linearity ranges from 2.16 to 324.53 µg/ml for AZT, and from 2.54 to 152.10 µg/ml for 3TC (r=1.000); mean recovery 100.3% (RSD=0.36%) for AZT and 99.73% (RSD=0.50%) for 3TC. The evaluation results showed that the accuracy and suitability of the method in the analysis of active ingredients AZT and 3TC on the PAMAM G3.0-F127@AZT/3TC dendrimer nano carrier system are adequate.