A VALIDATED STABILITY-INDICATING RP-HPLC METHOD FOR DETERMINATION OF ESMOLOL HYDROCHLORIDE AND ITS RELATED IMPURITIES

Esmolol Hydrochloride belongs to the class II anti-arrhythmic drugs. Due to composite compositions and low reproducibility, challenges are still warranted for the systematic method development for related substances and identification of its acid degradation products. Development, validation and characterization of RP-HPLC stability-indicating method for the quantitative analysis of two impurities in Esmolol hydrochloride and its stress degradants. The validation of this method was achieved as per ICH Q2 (R1) guidelines with the optimized experimental conditions. To achieve the proposed method on C₁₈ (250 mm × 4.6 mm, 5µ) column and the temperature was sustained at 30°C and run time was 12 min. The mobile phase consists of A–Acetonitrile, B–0.01N Potassium dihydrogen orthophosphate in water (pH=4.8). The injection volume of samples was 10μL, and UV detection was carried out at 221nm. Linearity ranges were covered 0.25-1.5 ppm for ASL-8123, ACC-9675 and Esmolol Hydrochloride. The newly developed method for separation of impurities along with the pure drugs was found to be capable of giving swift retention times while still preserving good resolution than that attained with conventional RP-HPLC. The proposed method has capable to separate these impurities with high resolution in bulk drug substance and hence this method can be used in the humdrum quality analysis in quality control samples and stability studies in bulk drugs.