Validation of a chiral HPLC assay for (R)-salbutamol sulfate

Halabi, Alejandra; Ferrayoli, Carlos G.; Palacio, Marcela A.; Dabbene, Viviana G.; Palacios, Sara M.

doi:10.1016/j.japna.2003.08.020

Cited by 44 publications

(23 citation statements)

References 15 publications

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“…The enantiomers of a chiral drug may have different pharmacological activities, i. e., both pharmacokinetic and pharmacodynamic effects, and the administration of only a single enantiomer in high enantiomeric purity is the major goal of the pharmaceutical industry [1]. Zolmitriptan ( Fig.…”

Section: Introductionmentioning

confidence: 99%

The study of enantioseparation of zolmitriptan on vancomycin-bonded chiral stationary phase

Zhang

Xu²,

2005

J. Sep. Science

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In this study, the chiral stationary phase was prepared by bonding vancomycin to 5 microm spherical silica gel according to "one-pot" synthetic strategies, and used to separate the enantiomers of zolmitriptan under polar ionic mode. The influences of mobile phase composition, such as the concentration and ratio of glacial acetic acid (HOAc) and triethylamine (TEA), on the enantioseparation were investigated, and the chiral recognition mechanism is discussed. It was found experimentally that the retention factors were increased with the increase of the HOAc/TEA concentration in a certain extent, and the ionic interactions, hydrogen bondings, and steric interactions may play key role together. The method is suitable for baseline separation of zolmitriptan enantiomers.

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Section: Introductionmentioning

confidence: 99%

The study of enantioseparation of zolmitriptan on vancomycin-bonded chiral stationary phase

Zhang

Xu²,

2005

J. Sep. Science

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“…The World Anti-doping Agency has prohibited the oral use of SAL, and a concentration of more than 1000 ng/mL in urine is considered as an indication of doping (Pichon, Venisse, Krupka, Perault-Pochat, & Denjean, 2006). Quantitative detection of SAL currently is limited to instrumental methods, high-performance liquid chromatography (Cooper & Shepherd, 1996;Halabi, Ferrayoli, Palacio, Dabbene, & Palacios, 2004;Maudens, Zhang, & Lambert, 2004;Mazhar & Chrystyn, 2009;Murtaza, Ahmad, & Akhtar, 2009), gas chromatography-mass spectrometry (Tanaka, Yoneda, Inoue, Sugiura, & Ueno, 2000;Zhang et al, 2006), capillary electrophoresis (Chen, Wang, Duan, Chen, & Chen, 2005;Chu, Geng, Zhou, & Ye, 2007;Felix et al, 2006), etc. Most of these methods share a number of important drawbacks.…”

Section: Introductionmentioning

confidence: 99%

Monoclonal antibody-based homogeneous immunoassay for three banned agonists and molecular modeling insight

Shen

Chen

et al. 2017

Food and Agricultural Immunology

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A homogeneous fluorescence polarization immunoassay (FPIA) was developed for the detection of an agonist salbutamol (SAL). Based on salbutamol-succinate-fluoresceinthiocarbamyl hexylenediamine (SAL-SUC-HDF), a fluorescein tracer with 6-carbon bridge was found to be more sensitive, the optimal FPIA showed the working range from 31.7 to 264.1 ng/mL with an IC 50 value of 91.4 ng/mL and a limit of detection 16.9 ng/mL. The cross-reactivity to brombuterol and clenbuterol was unexpectedly found to reach 447.3% and 255.8%, respectively. Computer-assisted molecular modeling revealed that the steric structure and electron density surfaces' effect appeared to be s two important factors to the broad-specific recognition to other agonists. ARTICLE HISTORY

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“…The literature survey reveals that, salbutamol is reported in USP [2]. Few HPLC methods are reported for the determination of salbutamol [3], related substances [4][5][6][7] and enantiomeric separation [8]. The IUPAC name of salbutamol is 4-[2-(tertbutylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol (Fig.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation of Salbutamol, Oxtriphylline and Bromhexine Hydrochloride in Tablet Dosage Form by RP-HPLC

Chakravarthi¹,

Devanna²

2017

Asian J. Chem.

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A simple, rapid, accurate, specific and stability indicating reverse phase HPLC method has been developed and validated for the simultaneous estimation of salbutamol, oxtriphylline and bromhexine hydrochloride in bulk drug and pharmaceutical tablet dosage form. The chromatographic separation was performed on the kromasil C18 column (250 mm × 4.6 mm, 5 µm particle size), using a mobile phase of orthophosphoric acid buffer:acetonitrile (65:35 v/v), at a flow rate of 1.0 mL/min at an ambient temperature of 25 °C with the detection wavelength at 260 nm. The retention times of salbutamol, oxtriphylline and bromhexine hydrochloride was found to be 2.03, 2.90 and 4.92 min, respectively. The proposed method has been validated for linearity, range, precision, accuracy and robustness were within the acceptance limit according to ICH Q2R1 guidelines. Quantification of the components in actual tablet formulations was calculated against the responses of freshly prepared external standard solutions. In the linearity test correlation coefficient was found to be 0.999 for all the molecules, percentage relative standard deviation (RSD) results from precision studies were 0.7, 0.2 and 0.3; mean percentage recoveries in accuracy studies were found to be 99.33, 99.44 and 99.36 % for salbutamol, oxtriphylline and bromhexine hydrochloride, respectively. Very low concentrations of LOD and LOQ indicate the method was highly sensitive enough. The designed validated method can be used effectively in the laboratory for regular determination of salbutamol, oxtriphylline and bromhexine hydrochloride in tablet formulation and bulk form.

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Validation of a chiral HPLC assay for (R)-salbutamol sulfate

Cited by 44 publications

References 15 publications

The study of enantioseparation of zolmitriptan on vancomycin-bonded chiral stationary phase

The study of enantioseparation of zolmitriptan on vancomycin-bonded chiral stationary phase

Monoclonal antibody-based homogeneous immunoassay for three banned agonists and molecular modeling insight

Simultaneous Estimation of Salbutamol, Oxtriphylline and Bromhexine Hydrochloride in Tablet Dosage Form by RP-HPLC

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