El-Sayed, Heba M. published the artcileQuality by Design Strategy for Simultaneous HPLC Determination of Bromhexine HCl and Its Metabolite Ambroxol HCl in Dosage Forms and Plasma, Application In Synthesis of 23828-92-4, the publication is Chromatographia (2020), 83(9), 1075-1085, database is CAplus.
Abstract: The quality by design strategy was applied for the simultaneous chromatog. quantification of a binary mixture of bromhexine HCl and its pharmacol. active metabolite ambroxol HCl in dosage forms as well as in human plasma. In this study, five independent parameters were screened by fractional factorial design to specify the critical ones. The optimal conditions were determined by a response surface methodol. using a central composite design. Response surface methodol. enabled the best separation in minimal run time, as well as, prediction of separation and retention parameters with min. error. Separation and quantitation were carried out on BDS Hypersil C8 (250 × 4.6 mm, 5μm) RP-column at 1.1 mL min-1 flow rate, 25 mM of KH2PO4 (pH 3.5) in aqueous mobile phase, 65% MeOH, 210 nm wavelength of detection and 10μL injection volume After optimization of the chromatog. parameters, validation of the method was achieved according to ICH guidelines. Linearity ranged from 0.195 to 100μg mL-1 ambroxol HCl, and 0.391-100μg mL-1 bromhexine HCl, with R2 values of 0.9998 and 0.9999 and limits of detection of 0.098 and 0.195μg mL-1, resp. Recovery results ranged from 98.06 to 100.18 and 97.88 to 100.68 for bromhexine HCl and ambroxol HCl, resp., with RSD less than 1.80.
Chromatographia 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, Application In Synthesis of 23828-92-4.
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