Determination of ambroxol in biological material by gas chromatography with electron-capture detection

Colombo, Laura; Marcucci, F.; Marini, Marina; Pierfederici, P; Mussini, E.

doi:10.1016/s0378-4347(00)82313-0

Cited by 43 publications

(23 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However, a 25-fold accumulation in lungs compared with plasma was shown to occur in patients and the "volume of distribution," i.e. total ABX in the body/ABX blood concentration, is high (560 liters) (69). Pharmacokinetics studies in rats have shown that ABX is widely distributed in lung, liver, kidney, and brain (62), i.e.…”

Section: Discussionmentioning

confidence: 99%

Identification and Characterization of Ambroxol as an Enzyme Enhancement Agent for Gaucher Disease

Maegawa

Tropak

Buttner

et al. 2009

Journal of Biological Chemistry

291

297

View full text Add to dashboard Cite

Gaucher disease (GD), the most prevalent lysosomal storage disease, is caused by a deficiency of glucocerebrosidase (GCase). The identification of small molecules acting as agents for enzyme enhancement therapy is an attractive approach for treating different forms of GD. A thermal denaturation assay utilizing wild type GCase was developed to screen a library of 1,040 Food and Drug Administration-approved drugs. Ambroxol (ABX), a drug used to treat airway mucus hypersecretion and hyaline membrane disease in newborns, was identified and found to be a pH-dependent, mixed-type inhibitor of GCase. Its inhibitory activity was maximal at neutral pH, found in the endoplasmic reticulum, and undetectable at the acidic pH of lysosomes. The pH dependence of ABX to bind and stabilize the enzyme was confirmed by monitoring the rate of hydrogen/deuterium exchange at increasing guanidine hydrochloride concentrations. ABX treatment significantly increased N370S and F213I mutant GCase activity and protein levels in GD fibroblasts. These increases were primarily confined to the lysosome-enriched fraction of treated cells, a finding confirmed by confocal immunofluorescence microscopy. Additionally, enhancement of GCase activity and a reduction in glucosylceramide storage was verified in ABX-treated GD lymphoblasts (N370S/N370S). Hydrogen/deuterium exchange mass spectrometry revealed that upon binding of ABX, amino acid segments 243-249, 310 -312, and 386 -400 near the active site of GCase are stabilized. Consistent with its mixedtype inhibition of GCase, modeling studies indicated that ABX interacts with both active and non-active site residues. Thus, ABX has the biochemical characteristics of a safe and effective enzyme enhancement therapy agent for the treatment of patients with the most common GD genotypes.

show abstract

Section: Discussionmentioning

confidence: 99%

Identification and Characterization of Ambroxol as an Enzyme Enhancement Agent for Gaucher Disease

Maegawa

Tropak

Buttner

et al. 2009

Journal of Biological Chemistry

291

297

View full text Add to dashboard Cite

show abstract

“…Methods available for the determination of Ambroxol hydrochloride include capillary electrophoresis [7][8][9] and, spectrophotometry [10], gas chromatography [11,12] and L.C. with potentiometric detection [13], MS detection [14] and UV detection [15][16][17][18].…”

Section: Introductionmentioning

confidence: 99%

Quantitative Determination of Levofloxacin and Ambroxol Hydrochloride in Pharmaceutical Dosage Form by Reversed-Phase High Performance Liquid Chromatography

Kothekar¹,

Jayakar²,

Khandhar³

et al. 2007

Eurasian J Anal Chem

View full text Add to dashboard Cite

The objective of this present work was to develop and validate analytical method for quantitative determination of Levofloxacin and Ambroxol hydrochloride in a new tablet formulation. Chromatographic separation of the two drugs were analyzed on a Hypersil BDS C18 column (25cm X 4.6mm, 5µm). The mobile phase constituted of Buffer: Acetonitirile: Methanol (650:250:100) with triethylamine and pH adjusted to 5.2 with dilute orthophosphoric acid was delivered at the flow rate 1.0 mL min -1 . Detection was performed at 220 nm. Separation was completed within 10 min. Calibration curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 7 to 22 µg mL -1 of Levofloxacin and 50 to 150 µg/mL for Ambroxol hydrochloride respectively. The relative standard deviation (R.S.D) was found <2.0%.

show abstract

“…Determination of AMB in biological fluids by capillary electrophoresis with fluorescence detection (Tomas et al, 2000), gas chromatography with electron Correspondence to: T. Sudha; E. mail: jvchrstysudha@gmail.com capture detection (Colombo 1990), capillary gas liquid chromatography (Schmid 1987), HPLC with amperometric detection (Flores et al, 1989) and LC-MS/MS (Hohyun et al, 2003) methods have been reported. Several methods have also reported for the determination of AMB like as AMB with bromhexine by capillary isotachophoresis (Polasek et al, 2001), simultaneous determination of AMB and cetirizine in their tablet formulation by absorbance ratio method (Kokil et al, 2008), determination of AMB and doxycycline by novel reversed phase sequential injection chromatography (Araujo et al, 2005), AMB in combination with BA (benzoic acid) in syrup as pharmaceutical dosage form for stress test as stability evaluation by HPLC (Maarit and Coral, 2001), AMB with MP and BA in pharmaceutical preparations based on sequential injection technique coupled with monolithic column (Dalibor et al, 2006), AMB with different preservatives in pharmaceutical formulations by HPLC (John et al, 2000).…”

Section: Introductionmentioning

confidence: 99%

High performance liquid chromatographic method for the determination of ambroxol hydrochloride in presence of antimicrobial preservatives in oral liquid formulation

Sudha¹,

Manthena²,

Ravikumar³

et al. 2015

Bangla Pharma J

View full text Add to dashboard Cite

A simple gradient reversed phase high performance liquid chromatographic method was developed for the determination of ambroxol hydrochloride in presence of antimicrobial preservatives in oral liquid formulation. The chromatographic separation was achieved by an Inertsil C 8 (250 X 4.6 mm, 5µ particle size) column using gradient technique. The eluents were detected at 245 nm with photodiode array detector. The optimized mobile phase consisted of 0.1% trifluoroacetic acid as a mobile phase A and a mixture of mobile phase A and acetonitrile in the ratio of 76:24 % v/v as mobile phase B. Ambroxol hydrochloride and microbial preservatives were eluted at a flow rate of 1.0 ml/min. The method validated according to the International Conference of Harmonization (ICH) guidelines. The calibration curves were linear over the (r 2 > 0.99) concentrations range from 300 to 900 ppm for ambroxol hydrochloride, 10 to 30 ppm for propyl paraben and 100 to 300 ppm for methyl paraben. The limit of detection was found to be 0.024 ppm for ambroxol hydrochloride, 0.018 ppm for propyl paraben and 0.009 ppm for methyl paraben. The percentage recoveries were found to be in the range from 99.55 to 101.1% for ambroxol hydrochloride, 100.31 to 101.46% for propyl paraben and 98.18 to 101.61% for methyl paraben. Stability indicating capability was established by forced degradation experiments. No chromatographic interference from the degradation products was found. The proposed method was highly sensitive, precision and accurate and hence successfully applied for the quantification of ambroxol active pharmaceutical ingredients (API) and preservatives content in the commercially available oral liquid formulation.

show abstract

Determination of ambroxol in biological material by gas chromatography with electron-capture detection

Cited by 43 publications

References 3 publications

Identification and Characterization of Ambroxol as an Enzyme Enhancement Agent for Gaucher Disease

Identification and Characterization of Ambroxol as an Enzyme Enhancement Agent for Gaucher Disease

Quantitative Determination of Levofloxacin and Ambroxol Hydrochloride in Pharmaceutical Dosage Form by Reversed-Phase High Performance Liquid Chromatography

High performance liquid chromatographic method for the determination of ambroxol hydrochloride in presence of antimicrobial preservatives in oral liquid formulation

Contact Info

Product

Resources

About