Development and Validation of an RP-HPLC Method for Estimation of Chlorpheniramine Maleate, Ibuprofen, and Phenylephrine Hydrochloride in Combined Pharmaceutical Dosage Form

The objective of this paper is to develope a simple, precise, accurate, and reproducible reversed phase high performance liquid chromatographic method for the quantitative determination of chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride in combined pharmaceutical dosage form. Analysis was carried out using acetonitrile？:？mathanol？:？phoshphate buffer (50？:？20？:？30, v/v/v, pH 5.6) mobile phase at 1.0？mL/min flow rate and Sunfire C 18 column (5？μm × 250？mm × 4.6？mm) as stationary phase with detection wavelength of 220？nm. The retention times of chlorpheniramine maleate (CPM), ibuprofen (IBU), and phenylephrine hydrochloride (PHE) were 4.2？min, 13.6？min, and 2.7？min, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. The linearity for chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride was in the range of 0.5–2.5？μg/mL, 25–125？μg/mL, and 1.25–6.25？μg/mL, respectively. The % recoveries of all the three drugs were found to be 99.44–101.61%, 99.39–101.79%, and 98.66–101.83%. LOD were found to be 32, 120, and 68？ng/mL for CPM, IBU, and PHE, respectively. The method was successfully applied to the estimation of chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride in combined pharmaceutical dosage form. 1. Introduction 3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine is the IUPAC name of the chlorpheniramine maleate (CPM). The empirical formula for CPM is C20H23ClN2O4 (Figure 1: chemical structure of CPM salt). CPM is a H-1 receptor blocker. CPM is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. 2-[4-(2-methyl-propyl)phenyl]propanoic acid is the IUPAC name of the ibuprofen (IBU). The empirical formula for IBU is C13H18O2 (Figure 2: chemical structure of IBU). IBU is a nonselective inhibitor of COX-2, an enzyme involved in prostaglandin synthesis of the arachidonic acid pathway. Its pharmacological effects are believed to be due to inhibition of COX-2 which decrease the synthesis of prostaglandin involved in mediating inflammation pain, fever, and swelling. (R)-1-(3-hydroxyphenyl)-2-methylamino-ethanol hydrochloride is the IUPAC name of phenylephrine hydrochloride (PHE). The empirical formula for PHE is C9H13NO2HCl (Figure 3: chemical structure of PHE). PHE is α-adrenoreceptor agonist, decreases nasal congestion, and increases drainage of sinus cavities. The combination dosage form of