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Table 7 Summary of validation parameters 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

Results

ICH limits

MET

ERTU

Retention time (min)

2.170

2.929

-

System suitability parameters

   

 % RSD

0.382

0.531

NLT 2.0

 Theoretical plates

9947

11679

MT 2000

 Tailing factor

1.25

1.23

NMT 2.0

Range (μg/ml)

62.5–375

0.9375–5.625

-

Linearity (R2)

0.999

0.999

NLT 0.999

% Recovery

99.11–101.13

99.27–100.60

98–102

% RSD

   

 Intra-day precision

0.42

0.25

NMT 1.0

 Inter-day precision

0.56

0.70

NMT 2.0

LOD (μg/ml)

0.87

0.025

-

LOQ (μg/ml)

2.63

0.076

-

% Assay difference at 24 h

1.51

1.74

NMT 2.0

% Assay

99.48

99.31

-