Development and Validation of First-Derivative Spectrophotometric Method for the Simultaneous Estimation of Lamivudine and Tenofovir disoproxil fumerate in Pure and in Tablet Formulation 

By Anandakumar Karunakaran, Kannan Kamarajan and Vetrichelvan Thangarasu 

ABSTRACT

This paper describes validated First Derivative Spectrophotometric method for the simultaneous estimation of Lamivudine and Tenofovir disoproxil fumerate in pure and in formulation. The solutions of standard and sample were prepared in distilled water. Quantitative determination of the drugs was performed at 287 nm and at 249 nm (N = 1; ?? = 1) for Lamivudine and Tenofovir disoproxil fumerate, respectively. Proposed method was evaluated for the different validation parameters. The specificity test showed that there was no interference from excipients commonly found in the commercial pharmaceutical formulations at the analytical wavelengths of LAM and TDF. Quantification was achieved over the concentration range of 5 – 30  µg/ ml for Lamivudine              and 10 – 60 µg/ ml for Tenofovir disoproxil fumerate. The mean recovery was 100.27 ± 1.2511 and 100.70 ± 1.0604 % for LAM and TDF, respectively. This method is simple, precise, and sensitive and applicable for the simultaneous determination of LAM and TDF in pure powder and formulation.  

Keywords: Lamivudine, Tenofovir disoproxil fumerate, First Derivative Specrophotometry, Method  Validation.

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