Chlorpheniramine Maleate injection (CPM) is a first-generation H1 antihistamine widely utilized for the management of allergic disorders. Thevarious pharmacopoeias currently employ UV spectroscopy method to determine the interference of preservative with API. This method lacks in sensitivity, specificity and robustness, particularly in the formulations as they contain various preservatives such as Chlorbutol, phenol, phenyl mercuric nitrate and benzyl alcohol, which interferes with the analysis. In order to overcome the limitation of the existing UV spectroscopic method, the present studies aim to design and develop a novel RP-HPLC method for the assay of chlorpheniramine maleate injection. Chromatographic separation of chlorpheniramine maleate and preservative was obtained by using C18 column (250mm× 4.6, 5µm) as stationary phase. The mobile phase consists of phosphate buffer (pH 3 adjusted with Ortho Phosphoric Acid) and acetonitrile in the ratio of 60:40 (v/v) at flowrate 1.0mL/min. The wavelength of the photo diode array detector was set at 265nm. The retention time was found to be 2.44min. The developed method was validated according to the ICH guidelines. i.e., linearity (R2=0.999 between 50-120%), precision (%RSD < 2%), system suitability,accuracy (recovery 98-102%), robustness and specificity. The developed method exhibited very good resolution, reproducibility and regulatory compliance. This method effectively exhibited no interferences with main peak. The research addresses a vital void in analytical technique for injectable chlorpheniramine maleate. Hence, the novel developed RP-HPLC method can be applied for the routine analysis of chlorpheniramine maleate injection.
