Method development and validation of tenofovir disoproxil fumerate and emtricitabine in combined tablet dosage form by UV-spectrophotometry and RP-HPLC
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2014, Vol 3, Issue 4
Abstract
A simple, accurate, rapid, precise and novel UV-Spectrophotometry and Reverse phase High Pressure liquid chromatographic method (RP-HPLC) has been developed and validated for simultaneous determination of Tenofovir Disoproxil Fumerate(TDF) And Emtricitabine(EMT) in combined tablet dosage form. At wavelength 260 nm both drugs have considerable absorbance. The UV-Spectrophotometry method was found to be linear between the range of 5-25 μg/ml for TDF and 7-35 μg/ml for EMT.The selected and optimized mobile phase was Acetonitrile : Phosphate pH 3.5 buffers in the ratio of 60:40 was fixed due to good symmetrical peak. and conditions were flow rate (1.0 ml/minute), wavelength (270 nm), Run time was 5 min. The retention time were found to be 2.85 min and 3.55 min for Tenofovir Disoproxil Fumerate And Emtricitabine respectively. Linearity and range was found to be 3-15 µg/ml for Tenofovir Disoproxil Fumerate and 2-10 µg/ml for Emtricitabine. The proposed chromatographic conditions were found appropriate for the quantitative determination of the drugs.The method was validated for accuracy, precision, specificity, linearity, robustness, sensitivity, LOD and LOQ. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible.
Authors and Affiliations
R Srinivasan
Keywords
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