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.