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Future Journal of Pharmaceutical Sciences

Table 1 System suitability

From: Stability-indicating method development and validation for the concurrent determination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide by UPLC in bulk and tablet dosage forms

Parameters

TAF

COBI

FTC

DRV

limit criteria

RSD of peak area (Injection repeatability)

0.2

0.8

0.5

0.2

< 2.0 for n ≥ 6

% RSD of retention time

0.442

0.394

0.503

0.437

< 1.0 for n ≥ 6

Tailing factor

1.2

1.2

1.366

1.264

T < 2

Plate count

5831.5

3093.4

3977.7

6053.2

N > 2000

Resolution

–

3.2

2.8

4.7

R > 2

  1. TAF tenofovir alafenamide, COBI cobicistat, FTC emtricitabine, DRV darunavir, n no. of determinations, T tailing factor, N  no. of plates, R resolution
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