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Table 2 Validation parameters of the proposed UPLC method for the determination of EMPA and its three related substances in spiked human plasma

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

Parameter EMPA in spiked human plasma ERS1 ERS2 ERS3
Range (ng/mL) 50–700 40–200 40–200 40–200
n 8 5 5 5
LOD (ng/mL)a 15 11.5 12 12.5
LLOQ (ng/mL)b 50 40 40 40
Accuracy
 Intra-dayc 97.09 97.86 99.28 96.97
 Inter-dayd 98.18 99.47 98.20 99.67
Precision ± %RSD
 Intra-dayc ± 6.38 ± 7.26 ± 7.94 ± 7.34
 Inter-dayd ± 6.63 ± 7.93 ± 6.60 ± 7.42
Linearity
 Slope 0.0003 0.0002 0.0005 0.0007
 Standard deviation of slope 5.7 × 10−6 5.8 × 10−6 7.6 × 10−6 6.8 × 10−6
 Intercept − 0.0016 − 0.0008 − 0.0004 − 0.0032
 Standard deviation of intercept 0.00001 0.00002 0.00001 0.00007
 Correlation coefficient (r) 0.9999 0.9994 0.9999 0.9997
  1. aLOD is the lowest detectable amount of the selected drug that could be detected
  2. bLLOQ is the lowest concentration of the analyte that can be measured accurately under the proposed experimental condition
  3. cThe intra-day study was performed for five concentrations for EMPA and its related substances (ERS 1–3), repeated three times within the day
  4. dThe inter-day study was performed for five concentrations for EMPA and its related substance (ERS 1–3), repeated three times in 3 successive days