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Representative chromatogram of FTC (9.56 minutes), TDF (12.65 minutes), and EFV (14.37 minutes) identified in the originator tablet formulation.

Representative chromatogram of FTC (9.56 minutes), TDF (12.65 minutes), and EFV (14.37 minutes) identified in the originator tablet formulation.

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South Africa has the world's largest antiretroviral (ARV) program and despite having stringent upstream medicine's regulatory oversight, the post-market reassessment of ARV quality is prohibitively resource intensive. The aim of this study was to evaluate and compare the post-market quality of four fixed-dose combination (FDC) generics containing e...

Context in source publication

Context 1
... gradient RP-HPLC method which was developed provided satisfactory separation of the peaks arising from FTC, TDF, and EFV in both standard injections (Fig. 2) and when the tablet sample was injected (Fig. 3). We found that the method showed robustness with respect to changes in pH (from 3.5 to 3.69) with a slight change in the retention times, while the decrease of the flow rate (from 1 to 0.8 ml/minute) increased the retention times of all the APIs, especially for EFV. The retention time increased from 9.53 to 10.56 minutes for FTC, 12.56 ...

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