title: Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques.
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.
authors: Analytical Research and Development, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad-500 072, India.
authors: Veera Raghava Raju
authors: VR
authors: Thummala
authors: School of Chemistry, Andhra University, Visakhapatnam-530003, A.P., India.
authors: Mrutyunjaya Rao
authors: MR
authors: Ivaturi
authors: School of Chemistry, Andhra University, Visakhapatnam-530003, A.P., India.
authors: Someswara Rao
authors: SR
authors: Nittala
keywords: Ambroxol; LC-MS/MS; NMR; RP-HPLC; Unknown impurity