Quantification Of (4-Bromophenyl){Pyridine-2-Yl} Acetonitrile Impurity (4-BPPA) By HPLC In Bromopheniramine Maleate Active Pharmaceutical Ingredient

Abstract

The aim of this research work is to develop a suitable HPLC method for the quantitative determination of process impurity (4-Bromophenyl) {Pyridine-2-yl} Acetonitrile as this compound is organic cyano compound hence it is necessary to quantify at ppm level presence of Brompheniramine Maleate Active Pharmaceutical Ingredient. Hence the HPLC method was developed on Instrument Waters 717 plus Auto Sampler, Waters 2487 Dual _ Absorbance Detector, Waters 2695 Separation Module, Waters 996 PDA Detector with Empower 2 Software on HPLC column Varian C18, 150 x 4.6 mm, 5μ at a flow rate of 1.5 mL/min. The limit of detection and the limit of quantitation for the impurity were established. Validation of the new developed HPLC method was carried out as per requirements of ICH guideline and the data shows that the proposed method is specific, linear, accurate, precise and robust. This method has been tested in a number of Brompheniramine Maleate samples and used successfully for quantification of the impurity at ppm level. The developed HPLC method was found to be suitable to quantify this impurity (4-Bromophenyl) {Pyridine-2-yl} Acetonitrile at ppm level present Brompheniramine Maleate.