[ Pharmaceutical Sciences Asia - ONLINE ]
Print ISSN 2586-8195 E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974

 
Abstracts

DOI: https://doi.org/10.14456/mujps.2016.4Pharm Sci Asia 2016; 43(1), 37-44
 

Simultaneous determination of paracetamol, phenylephrine, chlorpheniramine and related compound 4-aminophenol in multi-components pharmaceuticals by high performance liquid chromatography

P.T. Dung, K.X. Hai

- Faculty of Pharmacy, University of Medicine and Pharmacy, Ho Chi Minh City 41 Dinh Tien Hoang street, District 1, Ho Chi Minh city, Viet Nam


Nowadays, some pharmaceuticals consisted of paracetamol (PAR), phenylephrine hydrochloride (PHE), chlorpheniramine maleate (CPM) which use to reduce several symptoms associated with common cold are used widely. Together with quantitation of these compound, a related compound, 4-aminophenol (PAP) must be controlled. In the previous studies, quantitaion of these compounds were often conducted separately and some researches were confused about identification between chlorpheniramine and maleic acid. This research aims to develop a simple and rapid gradient reversed-phase high performance liquid chromatography method for simultaneous determination of paracetamol, phenylephrine, chlorpheniramine and limit related compound 4-aminophenol in pharmaceutical formulations. These compounds were separated on Eclipse XDB C18 column (250 x 4.6 mm i.d., size 5 μm) with a gradient elution using potassium dihydrogen phosphate buffer (pH 2.5) and acetonitrile as mobile phase. The flow rate of mobile phase was adjusted to 1.4 ml/min, temperature 35 oC and UV detection at wavelenghts of 265 nm for chlorpheniramine and 278 nm for paracetamol, phenylephrine and 4-aminophenol. The method was validated according to ICH guidelines and applied to assay in tablet dosage form without any interference from excipients. The validation characteristics included accuracy, precision, linearity, range, specificity, limit of detection (LOD). The linearity for all the drugs was obtained in the range of 190-455 μg/ml (PAR), 3-7 μg/ml (PHE), 1.2-2.8 μg/ml (CPM) and 0.25-20 μg/ml (PAP) with the correlation coefficients for linearity were in rank 0.9995 – 0.9999. The recovery of PAR, PHE, CPM was found in range 98 – 102% and the RSD of repeatability was found less than 2% . The LOD of 4-aminophenol was 0.0576 μg/ml. Thus, the proposed method can be successfully applicable to the pharmaceutical preparation containing the above mentioned drugs.


Keyword:

HPLC; 4-aminophenol; Paracetamol; Pheneylephrine; Chlorpheniramine maleate




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Vol.43
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October - December 2016

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