The author of 《Quality by design approach to develop stability indicating reversed-phase high-performance liquid chromatography method development for ambroxol》 were Ahmad, Sufiyan; Khabiya, Pranit; Au, Tatiya; Bakhshi, Abdurl Raheman. And the article was published in Asian Journal of Pharmaceutical and Clinical Research in 2021. Safety of trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol hydrochloride The author mentioned the following in the article:
As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial quality by design approach was established and validated for Ambroxol (AMB) by reversed-phase high-performance liquid chromatog. (RP-HPLC). A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, limit of detection (LOD), limit of quantitation (LOQ), accuracy as per International Conference for Harmonisation guidelines (Q2R1). Statistical data anal. was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Auto injector, UV diode-array detection and Gradient Detector. Equipped with Reverse Phase (Agilent) C18 column (4.6 mm x 100 mm; 2.5μm), a 20μl injection loop and UV730D Absorbance detector at 244 nm wave length and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% orthophosphoric acid) Water (75:25) of pH 3 as mobile phase setting flow rate 0.7 mL/min at ambient temperature the retention time of AMB were found to be 4.85 min. The industrialized method was found linear over the concentration range of 10-50μg/mL for AMB while the LOD and LOQ of AMB was found to be 0.5174-0.2739μg/mL, anal. method that concluded. There are no interfering peaks underperformed degradation conditions. Therefore, a sensitive, robust, accurate, and stability indicating method was developed with high degree of practical utility. In the experimental materials used by the author, we found trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol hydrochloride(cas: 23828-92-4Safety of trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol hydrochloride)
trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol hydrochloride(cas: 23828-92-4) is a mucolytic expectorant and a metabolite of bromhexine.Safety of trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol hydrochloride It is used in the treatment of respiratory disorders characterized by viscous or excessive mucus.
Referemce:
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