Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form

Figure 4

Results (%) of formulation tablet analysis and bulk drug batch sample analysis.

(a) Analysis of formulation 1 where imp-1 is not detected whereas imp-2 and unknown impurity are detected at 4.29 and 8.52 min, respectively

(b) Analysis of formulation 2 where imp-2 is detected at 4.29 min whereas imp-1 is not detected, respectively

(c) Analysis of bulk sample (B.NO. TAPE P1001) where both imp-1 and 2 are detected

(d) Analysis of bulk sample (B.NO. TAPE P1002) where both imp-1 and 2 are detected. SMUI was detected at 5.77 min, respectively

(e) Analysis of bulk sample (B.NO. TAPE P1003) where imp-2 is detected