Abstract
The main objective of present work was to develop simple spectrophotometric multicomponent method of analysis i. e. simultaneous equation method. Tenofovir disoproxil fumarate & Emtricitabine was first approved in US in July 2003 and is indicated for adults aged > or =18 years. This method is used for dissolution study of Tenofovir disoproxil fumarate and Emtricitabine in combined tablet dosage form. As per USFDA guidelines, dissolution study was carried out in 900 mL 0.01 N HCl. Dissolution study was carried out using a USP Type 2 (Paddle) apparatus at a stirring rate of 50 rpm for 45 minutes as per USFDA guidelines. Tenofovir disoproxil fumarate and Emtricitabine showed 258 and 286 nm as λmax in 0.01N HCl respectively. The drug release from tablet was evaluated by developed spectroscopic methods i. e. simultaneous equation method. At the end of 45 minutes, % Cumulative drug release of Emtricitabine & Tenofovir disoproxil fumarate was found to be 104.9 & 98.8 % based on developed method. The developed method was found to be simple, rapid, less tedious & economical compare to other reported methods in literature. The developed method can be a good alternative method for quality control testing of Emtricitabine & Tenofovir disoproxil fumarate in combined dosage form. Keywords: Tenofovir disoproxil fumarate, Emtricitabine, Simultaneous Equation method, Dissolution, USFDA
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