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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 -