DEVELOPMENT AND VALIDATION OF NEW RP HPLC METHOD FOR CONCURRENT DETERMINATION OF ACEBROPHYLLINE AND ERDOSTEINE IN SYNTHETIC MIXTURE

Abstract

A novel, simple, accurate and precise method for concurrent determination of Acebrophylline (ACB) and Erdosteine (ERB) in a blend by using RP-HPLC was developed. The analysis of the analyte was done by employing Inertsil ODS-3V C18 (5µ, 250 × 4.6 mm) as the stationary phase. The quantification of the ACB and ERB was done by using eluent as acetonitrile and a 50 mM potassium dihydrogen phosphate buffer with a 1.0 ml/min flow rate. The detection was set up at 250 nm. In compliance with ICH criteria (ICH Q2 (R1)), the analytical approach was successfully validated. By using the gradient method of acetonitrile and buffer, the peak of ACB and ERD was found to be at 5.47, 7.96 and 3.41 min, respectively. ACB and ERD showed linear response from 50-150 µg/mL and from 150-450 µg/mL, with correlation coefficient (R2) as 0.9997 and 0.9995, respectively. The percentage recovery for ACB and ERD was also determined to be 99.1–102.2% and 99.6–101.7%, respectively, falling well within the range of 98–102.2%. The current approach was found to be precise, accurate, robust and could be beneficially utilised for the concurrent analysis of ACB and ERD in dosage form.