World Journal of
Pharmaceutical and Life Sciences

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF EMTRICITABINE, TENOFOVIR AF, DOLUTEGRAVIR IN ITS BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

Syeda Shafaq* and Dr. R. Vani

ABSTRACT

A short selective, precise, accurate and sensitive for the estimation of Emtricitabine, Tenofovir AF and Dolutegravir was done by RP-HPLC. During the stress study, the degradation products were well-resolved from its impurities and the mass balances were found to be satisfactory in all the stress conditions, thus proving the stability-indicating capability of the method. The assay of Emtricitabine, Tenofovir AF and Dolutegravir was performed with tablets and the % assay was found to be 99.93 and 100.92 and 100.03 which shows that the method is useful for routine analysis. The linearity of Emtricitabine, Tenofovir AF and Dolutegravir was found to be linear with a correlation coefficient of 0.999 and 0.999 and 0.999 which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show precision 0.8 and 0.3 and 0.8 for Emtricitabine, Tenofovir AF and Dolutegravir which shows that the method is precise.

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