Chromatography Research International / 2012 / Article / Tab 4

Research Article

Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib

Table 4

Regression data.

ParameterBortezomibImp-AImp-BImp-CImp-DImp-EImp-FImp-GImp-HImp-I

LOD (μg/mL) 0.043 0.012 0.025 0.043 0.043 0.047 0.038 0.045 0.024 0.060
LOQ (μg/mL) 0.174 0.048 0.100 0.173 0.174 0.188 0.152 0.179 0.097 0.239
Regression equation (y)
Slope (b)
13289 22831
20852
12009
13934
14688 19330
17640
15812
8765
Intercept (a)
−404
−309 −296
130
45
−386
344 −486
−397
617
Correlation coefficient
0.9995
0.9995
0.9998
0.9993
0.9995
0.9993
0.9994
0.9997 0.9998 0.9996

Linearity range is LOQ-150% with respect to 1.0 mg/mL of bortezomib for impurities;
Linearity range is 50–150% with respect to 1.0 mg/mL of bortezomib for assay.

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