Table 6 The results of robustness study of IMG assay and dissolution.

From: Stability indicating green HPLC method for Imeglimin hydrochloride determination in pharmaceutical tablets with comprehensive assessment

Method

Condition

Conc. taken

(µg. mL− 1)

T

N

Mean**

% recovery

SD

RSD (%)

Pooled

RSD (%)

Flow rate (mL. min− 1)

 Assay

0.95

1.00*

1.05

40.0

0.9734

0.9762

0.9798

5826

5686

5488

98.81

99.77

98.68

0.43

0.78

0.45

0.435

0.784

0.453

0.72

 Dissolution

0.95

1.00*

1.05

40.0

0.948

0.956

0.951

5234

5440

5185

99.26

99.28

99.00

0.123

0.096

0.047

0.124

0.097

0.047

0.16

Column temperature (̊C)

 Assay

38

40*

42

40.0

0.9718

0.9732

0.9741

5552

5686

5466

99.38

99.77

98.90

0.402

0.782

0.449

0.405

0.784

0.454

0.63

 Dissolution

38

40*

42

40.0

0.954

0.956

0.932

5466

5440

5033

99.20

99.28

98.92

0.142

0.096

0.112

0.143

0.097

0.113

0.19

  1. *Optimum chromatographic conditions, **Average of three determinations, T: USP tailing Factor, N: number of theoretical.
  2. plates.