RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IMPURITIES FROM EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET

Stability indicating RP-HPLC gradient method developed for simultaneous determination of impurities and degradation products from Emtricitabine and Tenofovir Disoproxil Fumarate in pharmaceutical tablet dosage form. The chromatographic separation was achieved by using column ACE C18 (250 x 4.6, 5μ). The mobile phase-A consists of 0.01M potassium dihydrogen phosphate buffer with pH 4.0 adjusted using diluted ortho-phosphoric acid and mobile phase-B as methanol. The flow rate was 1mL min-1 throughout the gradient program with detection wavelength of 270 nm for both components with its related impurities. The column temperature was 30°C and injection volume of 20µl. A well separation of degradation products from main peak and respective known impurities was found with resolution between adjacent peaks greater than 2.0. The method found linear from LOQ to 0.4% level for all impurities with respect to concentration for Emtricitabine(0.7 mg/mL) and Tenofovir Disoproxil Fumarate (1.06 mg/mL) The developed method was validated for specificity, linearity, precision, LOD, LOQ, accuracy and robustness as per ICH guideline Q2A (R1). The results were indicating that the method was selective and stability indicating for determination of impurities from Emtricitabine and Tenofovir Disoproxil Fumarate tablet dosage form