Determination of ambroxol hydrochloride, methylparaben and benzoic acid in pharmaceutical preparations based on sequential injection technique coupled with monolithic column

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 40; no. 2; pp. 287 - 293
• Main Authors: Šatínský, Dalibor, Huclová, Jitka, Ferreira, Raquel L.C., Montenegro, Maria Conceição B.S.M., Solich, Petr
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 13.02.2006; Elsevier Science
• Subjects: Ambroxol - analysis; Ambroxol hydrochloride; Analysis; Analytical, structural and metabolic biochemistry; Benzoic acid; Benzoic Acid - analysis; Biological and medical sciences; Chromatography, Liquid - methods; Expectorants - analysis; Fundamental and applied biological sciences. Psychology; General pharmacology; Medical sciences; Methylparaben; Monolithic columns; Parabens - analysis; Pharmaceutical Preparations - chemistry; Pharmacology. Drug treatments; Preservatives, Pharmaceutical - analysis; Reproducibility of Results; Sequential injection analysis (SIA); Sequential injection chromatography (SIC); Spectrophotometry, Ultraviolet; Benzoic acid; Sequential injection analysis (SIA); Monolithic columns; Methylparaben; Ambroxol hydrochloride; Sequential injection chromatography (SIC); Sequential analysis; Ambroxol; Expectorant; Quantitative analysis
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2005.07.032

The porous monolithic columns show high performance at relatively low pressure. The coupling of short monoliths with sequential injection technique (SIA) results in a new approach to implementation of separation step to non-separation low-pressure method. In this contribution, a new separation method for simultaneous determination of ambroxol, methylparaben and benzoic acid was developed based on a novel reversed-phase sequential injection chromatography (SIC) technique with UV detection. A Chromolith ® SpeedROD RP-18e, 50-4.6 mm column with 10 mm precolumn and a FIAlab ® 3000 system with a six-port selection valve and 5 ml syringe were used for sequential injection chromatographic separations in our study. The mobile phase used was acetonitrile–tetrahydrofuran–0.05 M acetic acid (10:10:90, v/v/v), pH 3.75 adjusted with triethylamine, flow rate 0.48 ml min −1, UV-detection was at 245 nm. The analysis time was <11 min. A new SIC method was validated and compared with HPLC. The method was found to be useful for the routine analysis of the active compounds ambroxol and preservatives (methylparaben or benzoic acid) in various pharmaceutical syrups and drops.