The author of 《Stability indicating RP-HPLC method for simultaneous determination of H1- histamine receptor antagonist and mucolytic agent in marketed formulation》 were Jayaprakash, M.; Puranik, S. B.; Gowri, R.. And the article was published in International Journal of Pharmacy and Pharmaceutical Research in 2020. Reference of trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol hydrochloride The author mentioned the following in the article:
RP-HPLC method has been developed for simultaneous determination of Stability indicating HPLC method was developed for the simultaneous estimation of Ambroxol hydrochloride and Levocetirizine dihydrochloride in marketed formulation. The HPLC system used was SHIMADZU UFLC-2000 Prominence LC20AD SPDM 20A Binary Gradient System with Rheodyne injector 20μL and the column Enable C18 250 x 4.6 mm, 5μm. The mobile phase comprised of Phosphate buffer (pH 3.0): Methanol in the ratio of 20:80 volume/volume and flow rate of 1.0 mL/min with PDA detection at 236 nm produced peaks of Ambroxol hydrochloride and Levocetirizine dihydrochloride in the chromatogram which was well resolved with a retention time of 3.4 min and 4.7 min resp. The developed HPLC method was validated for various parameters like accuracy, precision, specificity, LOD, LOQ, linearity, range, and robustness as per ICH guidelines. The results obtained were well within the acceptance criteria for all the parameters. The proposed method was applied for the simultaneous estimation of Ambroxol hydrochloride and Levocetirizine dihydrochloride in marketed formulations (capsule). The assay results conformed to the label claim of the formulation. Hence the proposed method can be used for the routine anal. of Ambroxol hydrochloride and Levocetirizine dihydrochloride in their marketed capsule dosage formulations. Forced degradation studies were carried out in Acidic medium, Alk. medium, Oxidation condition, Thermal condition, and Photostability condition and it was found that the degradation and the peaks of degraded products did not interfere with the method. Hence the developed and validated HPLC method can be employed for routine anal. of Ambroxol hydrochloride and Levocetirizine dihydrochloride in marketed formulations. The results obtained were within the acceptance criteria for the parameter. The proposed methods were applied for the estimation of Ambroxol hydrochloride and Levocetirizine dihydrochloride in marketed formulations. Hence the proposed method was found to be satisfactory and could be used for the routine anal. of Ambroxol hydrochloride and Levocetirizine dihydrochloride in their marketed capsule dosage formulations. In the experiment, the researchers used trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol hydrochloride(cas: 23828-92-4Reference 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.Reference 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.
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