Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques

Veera Raghava Raju THUMMALA; Mrutyunjaya Rao IVATURI; Someswara Rao NITTALA

doi:10.3797/scipharm.1310-21

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Article

12 January 2014

Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques

and

Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India

School of Chemistry, Andhra University, Visakhapatnam-530003, A.P., India

Author to whom correspondence should be addressed.

Sci. Pharm.2014, 82(2), 247-264;https://doi.org/10.3797/scipharm.1310-21

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Abstract

This study details the isolation, identification, and characterization of ambroxol’s unknown impurity. One unknown impurity of ambroxol was formed in the formulated drug under stress conditions [40°C /75% relative humidity (RH) for 6 months] with the relative retention time (RRT) 0.68 in RP-HPLC. The impurity was enriched by exposing it to heat and it was isolated by using preparative HPLC. The enriched impurity was purified and characterized using the following sophisticated techniques: 2D NMR (gDQ-COSY, gHSQC, and gHMBC), FTIR, and LC-MS/MS. On the basis of the spectral data, the impurity was characterized as trans-4-(6,8-dibromoquinazolin-3(4H)-yl)cyclohexanol.

Keywords:

Ambroxol; RP-HPLC; Unknown impurity; NMR; LC-MS/MS

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