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Table 4 System suitability parameters of the current HPLC method for the determination of EMP, LIN, and MET along with MEL and CYG as MET potential official impurities

From: HPLC-DAD technique for the quantification of a recently approved anti-diabetic triple combination along with two toxic official impurities: Toxicity confirmation aided by molecular docking application

Parameter

MET

 

MEL

 

CYG

 

LIN

 

EMP

Reference value [27]

Selectivity(α)c

 

1.23

 

1.19

 

1.23

 

1.20

 

≥ 1

Resolution(Rs)d

 

2.14

 

3.24

 

3.32

 

5.34

 

> 2

Capacity factor (K’)

1.02

 

2.34

 

6.54

 

7.43

 

8.32

1–10

Tailing factor(T)

1.12

 

1.22

 

1.18

 

1.17

 

1.18

≤ 2

Column efficiency (N)

2165

 

2534

 

3455

 

6543

 

7544

The higher the value, the more efficient the column is

Height equivalent to theoretical plate(cm/plate)

0.01154

 

0.00986

 

0.00723

 

0.00382

 

0.00331

The smaller the value, the higher the column efficiency

Retention time (Rt, min)

1.79

 

2.21

 

2.65

 

3.26

 

3.92

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  1. MET, metformin; MEL, melamine; CYG, cyanoguanidine; LIN, linagliptin; EMP, empagliflozin