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

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

1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
School of Chemistry, Andhra University, Visakhapatnam-530003, A.P., India
*
Author to whom correspondence should be addressed.
Received: 24 October 2013 / Accepted: 12 January 2014 / Published: 12 January 2014
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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 Ambroxol; RP-HPLC; Unknown impurity; NMR; LC-MS/MS
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

THUMMALA, V.R.R.; IVATURI, M.R.; NITTALA, S.R. Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques. Sci. Pharm. 2014, 82, 247-264.

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