Development and Validation of a Rp-Hplc Method for the Determination of Chlorpheniramine Maleate and Phenylephrine in Pharmaceutical Dosage Form

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Maithani M et al. / Pharmacie Globale (IJCP) 2010, 5 (05)

Available online at www.pharmacie-globale.info

ISSN 0976-8157

Research Article

PHARMACIE GLOBALE
INTERNATIONAL JOURNAL OF COMPREHENSIVE PHARMACY

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE DETERMINATION OF CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE IN PHARMACEUTICAL DOSAGE FORM
Mukesh Maithani*, Richa Raturi, Vertika Gautam, Dharmendra Kumar, Amrendra Kumar Chaudhary, Anand Gaurav and Ranjit Singh
School of Pharmaceutical Sciences, Shobhit University, NH-58, Modipuram, Meerut, Uttar Pradesh (250 110), India. Received: 6 November 2010; Revised: 29 November 2010; Accepted: 9 December 2010; Available online: 12 December 2010

ABSTRACT

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of chlorpheniramine maleate and phenylephrine in tablet dosage forms. A reversed-phase C-18 column (250 mm × 8 mm i.d., particle size 10 µm) column with mobile phase consisting of acetonitrile and phosphate buffer 55:45 (v/v) (pH 5.6 ± 0.02, adjusted with triethylamine) was used. The flow rate was 1.0 ml/ min and effluents were monitored at 255 nm. The retention times of chlorpheniramine maleate and phenylephrine were found to be 3.13 min and 4.58 min, respectively. The method was validated in terms of linearity, range, specificity, accuracy, precision, limit of detection (LOD) and limit of quantitation (LOQ). The linearity for both the drugs was found in the range of 10-70 μg/ml. The % recoveries of chlorpheniramine maleate and phenylephrine were found to be between 101.09 and 98.99. The proposed method was successfully applied to the estimation of chlorpheniramine maleate and phenylephrine in combined tablet dosage forms. Keywords: Chlorpheniramine maleate, phenylephrine, simultaneous estimation, RP-HPLC, tablet dosage forms.

INTRODUCTION

Chlorpheniramine maleate (CM) chemically, 3-(4chlorophenyl)-N, N-dimethyl-3-pyridin-2-ylpropan-1amine is an antihistamine drug that is widely used in pharmaceutical preparations for symptomatic relief of

common cold and allergic diseases. Phenylephrine (PE)
chemically, (1R)-1-(3hydroxy-phenyl)-2-(methylamino)
ethanol hydrochloride is used as a sympathomimetic.1-4
The structures of CM and PE are shown in (Figure 1).
Numerous UV, HPLC and HPTLC based methods have been
reported for estimation of these drugs alone as well as in
combination with other drugs in pharmaceutical dosage
forms.5-14 But no method had yet been reported for
simultaneous estimation of these two drugs using HPLC in
bulk drug and pharmaceutical dosage forms. Therefore,
the present work was aimed to develop and validate a new
RP- HPLC method for simultaneous estimation of CM and
PE in pharmaceutical dosage forms.
Figure 1. The structures of chlorpheniramine maleate
(CM) and phenylephrine (PE)
Cl

N

CH3 HCCOOH
C CH2CH2N
. CHCOOH
H
CH3

Chlorpheniramine maleate (CM)
*Corresponding Author:
Mukesh Maithani
Lecturer, School of Pharmaceutical Sciences,
Shobhit University, NH-58, Modipuram,
Meerut, Uttar Pradesh- 250 110, India.
Contact no: +91-9758860810
Email: mukeshmaithani@gmail.com

1

HO

OH
C CH2NHCH3.HCl
H
Phenylephrine (PE)

MATERIALS AND METHODS
Chemicals and Reagents
Reference standards of CM and PE were procured as gift
samples from Torrent Pharmaceutical (Gandhinagar,
India). HPLC grade acetonitrile, water and triethylamine
were obtained from Rankem, RFCL Limited, New Delhi,
India. Potassium dihydrogen orthophosphate AR and
ortho phosphoric acid AR grade were procured from
Central Drug House (P) Limited, New Delhi, India.
Instrumentation
The HPLC (PerkinElmer series 200) instrument equipped
with a model series 200 pump, vacuum degasser,
rheodyne injector with a 20μl loop, UV-Visible detector
and C-18 column was used.
Chromatographic Conditions
The isocratic mobile phase was consisted of...
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