Abstract

Stability Indicating RP-UPLC-PDA Method Development, Validation of Multi Drug Combination of Emtricitabine, Tenofovir Alafenamide and Rilpivirine in Bulk Drug and its Tablet Formulation

Imam Pasha. S¹, Murali Balaram.Varanasi¹ and Ibrahim Mohammed²

DOI : http://dx.doi.org/10.13005/ojc/330243

Abstract:

Stability representing Ultra Performance LC method was developed for Assay of multi drug Combination of Rilpivirine, Emtricitabine and Tenofovir alafenamide in bulk active pharmaceutical ingredients and its tablet formulation, Validation was performed for all parameters .Retention times of Reference Standard Emtricitabine, Tenofovir Alafenamide and Rilpivirine was found to be 0.965, 1.528, 2.186 with the flow rate of 0.3 mille liters per minute by Injecting Volume of 2 micro liters by maintaining Run time of 3 minutes. Developed method was subjected to forced degradation studies under specified conditions, which meets the required criteria. Degradation product at 1.975 was collected under various stress condition, degradation of imidazole ring of tenafovir alafenamide confirmed with Proton NMR, ESI–MASS in + MODE.

Keywords:

RP-UPLC-PDA; Emtricitabine; Tenofovir Alafenamide; Rilpivirine

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