DEVELOPMENT AND VALIDATION OF AN RP- HPLC METHOD FOR ESTIMATION OF CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE IN PHARMACEUTICAL DOSAGE FORM

Shweta R. Yadav* and Prof. Chetana Bapu Gavale

ABSTRACT

The main objective of this paper is to developed a simple, precise, accurate, and reproducible reversed phase high performance liquid chromatographic method for the quantitative determination of chlorpheniramine maleate and phenylephrine hydrochloride in pharmaceutical dosage form. 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, RP-HPLC, tablet dosage forms.