Ahmad, Sufiyan published the artcileQuality by design approach to develop stability indicating reversed-phase high-performance liquid chromatography method development for ambroxol, Quality Control of 23828-92-4, the publication is Asian Journal of Pharmaceutical and Clinical Research (2021), 14(12), 44-49, database is CAplus.
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.
Asian Journal of Pharmaceutical and Clinical Research published new progress about 23828-92-4. 23828-92-4 belongs to alcohols-buliding-blocks, auxiliary class Membrane Transporter/Ion Channel,Sodium Channel, name is trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol hydrochloride, and the molecular formula is C13H19Br2ClN2O, Quality Control of 23828-92-4.
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