HPLC method for the determination of emtricitabine and related degradation substances.

A new high-performance liquid chromatography method has been developed for a stability-indicating assay for emtricitabine and the quantification of its related substances. Good resolution between the peaks corresponds to process-related impurities, and degradation products from the analyte were achieved on a C18 HiQSil column using a mobile phase consisting of ammonium formate (pH 4.2) and methanol in a gradient elution mode.