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Article

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.
Sci. Pharm. 2014, 82(2), 247-264; https://doi.org/10.3797/scipharm.1310-21
Submission received: 24 October 2013 / Accepted: 12 January 2014 / Published: 12 January 2014

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

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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. https://doi.org/10.3797/scipharm.1310-21

AMA Style

THUMMALA VRR, IVATURI MR, NITTALA SR. Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques. Scientia Pharmaceutica. 2014; 82(2):247-264. https://doi.org/10.3797/scipharm.1310-21

Chicago/Turabian Style

THUMMALA, Veera Raghava Raju, Mrutyunjaya Rao IVATURI, and Someswara Rao NITTALA. 2014. "Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques" Scientia Pharmaceutica 82, no. 2: 247-264. https://doi.org/10.3797/scipharm.1310-21

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