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Table 6 Robustness of ERTU and MET

From: Development and validation of stability-indicating RP-HPLC method for the simultaneous determination of ertugliflozin pidolate and metformin hydrochloride in bulk and tablets

Parameter Modified condition % RSD of peak area (NMT 2.0 %) Theoretical plates* N (> 2000) Tailing factor* (< 2.0) Rs* (> 2.0)
ERTU MET ERTU MET ERTU MET
Flow rate (ml/min) 0.9 0.893 1.209 12,959 10,911 1.17 1.17 7.96
1.0 0.531 0.382 11,679 9947 1.23 1.33 7.21
1.1 0.949 1.113 11,564 9463 1.21 1.16 7.63
ACN ratio in mobile phase
Buffer: ACN (% v/v)
70:30 1.377 1.039 11,949 11,751 1.26 1.15 9.2
65:35 0.531 0.382 11,679 9947 1.23 1.33 7.21
60:40 1.360 1.293 12,741 9485 1.22 1.14 6.78
Temperature (°C) 25 0.912 1.278 13,396 9470 1.14 1.20 7.03
30 0.531 0.382 11,679 9947 1.23 1.33 7.21
35 0.574 0.993 13,396 9516 1.21 1.17 7.01
  1. * All the values were expressed as mean of six determinations