Stability-Indicating Gradient RP-LC Method for the Determination of Process and Degradation Impurities in Bosentan Monohydrate: An Endothelin Receptor Antagonist
Table 4
Results (%) of formulation tablet analysis and bulk drug batches sample analysis.
Sample source
Imp-A
Imp-B
Imp-C
Imp-D
Imp-E
SMUI
Formulation product analysis results
Formulation-1
0.02
0.11
ND
ND
ND
0.06
Formulation-2
0.03
0.11
ND
ND
ND
0.07
Batch analysis results (%)
B.NO. BOSPP10001
0.02
0.09
0.02
ND
ND
0.05
B.NO. BOSPP10002
0.01
0.07
0.03
ND
ND
0.04
B.NO. BOSPP10003
ND
0.03
0.02
ND
ND
0.03
ND: Not detected; SMUI: Single maximum unknown impurity.