Abstract
During the process development of Salmeterol, an unknown impurity was detected at 2.08 Relative Retention Time (RRT) at a level of 0.11% by a gradient Reverse Phase-High Performance Liquid Chromatography (RP-HPLC). The impurity was isolated from the salmeterol drug substance using preparative HPLC. The separation was achieved with an Inertsil C8 column, using acetonitrile–trifluroacetic acid buffer pH 2.7 as mobile phase. The isolated impurity was characterized by NMR and MS techniques. The impurity has been characterized as 4-(2-{[6-(4-cyclohexylbutoxy)hexyl]amino}-1-hydroxyethyl)- 2-(hydroxymethyl)phenol. The synthesis of the impurity and its formation was also discussed.
Highlights
We discuss the isolation and characterization of the target impurity in salmeterol
The unknown impurity under study is marked as target impurity, which was eluted at retention time (RT)
The impurity was isolated from the mother liquor of Salmeterol by preparative HPLC
Summary
We discuss the isolation and characterization of the target impurity in salmeterol. Isolation and Characterization of a Trace Level Unknown Impurity of Salmeterol ... Chemical structures of Salmeterol and the Target Impurity The impurity was isolated from the mother liquor of Salmeterol by preparative HPLC. Isolation of the impurity by preparative HPLC
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