Skip to main content

Table 1 System suitability parameters by the proposed UPLC method

From: A UPLC/DAD method for simultaneous determination of empagliflozin and three related substances in spiked human plasma

Parameters ERS1 EMPA ERS2 ERS3 IS Recommended valuea
Retention time 0.511 0.606 0.68 0.849 1.040
− k′ 1.55 2.12 2.49 3.26 4.39 1–10 acceptable
α 1.37 1.17 1.31 1.76 > 1
Rs 2.15 2.01 5.51 7.81 > 2
T 0.95 1.01 1.05 0.98 1.3 ≤ 2
T = 1 for a typical symmetric peak
N 12,890 3920 4023 13,205 4527 2000–10,000 increases with efficiency of the separation
  1. aValues defined by FDA Center of Drug Evaluation and Research’s reviewer guidance on validation of chromatographic methods [25]