Maithani M et al. / Pharmacie Globale (IJCP) 2010, 5 (05) 1 Pharmacie Globale (IJCP), Vol. 01, Issue 05 Available online at www.pharmacie-globale.info 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 INTRODUCTION Chlorpheniramine maleate (CM) chemically, 3-(4- chlorophenyl)-N, N-dimethyl-3-pyridin-2-ylpropan-1- amine 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) C N H CH 2 CH 2 N CH 3 CH 3 . HCCOOH CHCOOH Cl 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 C OH H CH 2 NHCH 3. HCl HO 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 acetonitrile and phosphate buffer 55:45 (v/v) (pH 5.6 ± 0.02, adjusted with triethylamine). The mobile phase was sonicated for 15 min and filtered through a 0.45 μ membrane filter paper. Flow rate of mobile phase was 1.0 ml/min. The variable wavelength UV–visible detector was set at 255 nm. All analyses were performed at ambient temperature. Preparation of Standard Stock Solution 25 mg CM and 25 mg PE were accurately weighed and transferred to 100 ml volumetric flasks separately and 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. Research Article ISSN 0976-8157