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Drug Res (Stuttg) 2014; 64(5): 251-256
DOI: 10.1055/s-0033-1357191
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Gradient HPLC-DAD Determination of Paracetamol, Phenylephrine Hydrochloride, Cetirizine in Tablet Formulation

A. P. Dewani
1   Department of Quality Assurance, Pataldhamal Wadhwani College of Pharmacy, Maharashtra, India
,
P. G. Shelke
1   Department of Quality Assurance, Pataldhamal Wadhwani College of Pharmacy, Maharashtra, India
,
R. L. Bakal
1   Department of Quality Assurance, Pataldhamal Wadhwani College of Pharmacy, Maharashtra, India
,
S. S. Jaybhaye
1   Department of Quality Assurance, Pataldhamal Wadhwani College of Pharmacy, Maharashtra, India
,
A. V. Chandewar
1   Department of Quality Assurance, Pataldhamal Wadhwani College of Pharmacy, Maharashtra, India
,
S. Patra
2   University Department of Pharmaceutical Sciences, Utkal University, Bhubaneswar
› Author Affiliations
Further Information

Publication History

received 21 August 2013

accepted 12 September 2013

Publication Date:
16 October 2013 (online)

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Abstract

Present work describes the development and validation of a simple and reliable high-performance liquid chromatography-diode array detection (HPLC-DAD) procedure for the analysis of phenylephrine hydrochloride (PHE), paracetamol (PAR) and cetirizine dihydrochloride (CET), in pharmaceutical mixture. The method was applied successfully on tablet dosage form. Effective chromatographic separation of PHE, PAR and CET was achieved using a Kinetex-C18 (4.6, 150 mm, 5 mm) column with gradient elution of the mobile phase composed of 10 mM phosphate buffer (pH 3.3) and acetonitrile. The elution was a 3 step gradient elution program step-1 started initially with 2% (by volume) acetonitrile and 98% phosphate buffer (pH 3.3) for first 2 min. In step-2 acetonitrile concentration changed linearly to 20% upto 12 min the analysis was concluded by step-3 changing acetonitrile to 2% upto 20 min. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to linearity, ranges, precision, accuracy, selectivity and robustness. Calibration curves were linear in the ranges 5–15, 250–750 and 2.5–7.5 μg/ml for PHE, PAR and CET, with correlation coefficients >0.9996. The validated HPLC method was applied to a pharmaceutical mixture of a marketed preparation tablet in which the analytes were successfully quantified with good recovery values with no interfering peaks from the excipents.

Key words

phenylephrine - paracetamol - cetirizine - HPLC-DAD
 

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