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Table 2 Regression and validation 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

Method parameter

Current HPLC method

EMP

LIN

MET

CYG

MEL

Linearity range

0.2–8.0

 µg/mL

0.3–9.0

 µg/mL

1.0–250.0

 µg/mL

1.0–100.0

 µg/mL

1.0–100.0

 µg/mL

Slope

116.407

38.804

183.342

8.262

91.431

Intercept

-3.772

-1.964

-17.832

0.492

-14.033

Correlation coefficient (r)

0.9999

0.9999

0.9999

0.9999

0.9999

LODa

0.05

0.09

0.19

0.2

0.1

LOQa

0.15

0.27

0.58

0.9

0.8

Precision

% RSD

Intra-dayb

0.438

0.311

0.621

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Inter-dayc

0.212

0.540

0.275

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  1. a LOD and LOQ are calculated according to ICH, 3.3 × SD of the intercept/slope and 10 × SD of the intercept /slope, respectively
  2. bIntra-day precision [average of three different concentrations of three replicates each (n = 9) within the same day]
  3. cInter-day precision [average of three different concentration of three replicates each (n = 9) repeated on 3 successive days