A novel simultaneous determination of stability indicating method was developed for three combination drug product, the commercially available Atripla tablets were used for development, commercially available tablet combination of the Emtricitabine, Efavirenz, and Tenofovir. The developed novel isocratic HPLC method able to separate the three compounds in shorter runtime than reported methods and offering minimum usage of chemical reagents. The separations was achieved on Kromosil C18 100 x 4.6,3.5µ Column, Mobile phase 0.1M ortho phosphoric acid buffer and Acetonitrile in 60:40 v/v ratio, at flow rate of 0.5 mL/min and detection wavelength at 265 nm. The drug product was subjected to various stress conditions as per ICH stress conditions. The developed method was validated with respect to specificity, linearity, accuracy, precision, ruggedness and robustness as per ICH guidelines. The developed method transferred to Quality control for routine testing and stability studies.
Cite this article:
P. Sreelatha, B. Rama Devi. Development and Validation of Stability-indicating HPLC method for simultaneous estimation of Tenofovir, Emtricitabine and Efavirenz in fixed dose combination drug product. Asian J. Research Chem. 2018; 11(1):23-31. doi: 10.5958/0974-4150.2018.00006.8