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


Author: S. M. Rathod, N. C. Patel, N. B. Mehta and C. S. Kolakaluri
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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 byusing eluent as acetonitrile and a 50 mM potassium dihydrogen phosphate buffer with a 1.0 ml/min flowrate. Thedetection was set up at 250 nm. In compliance with ICH criteria (ICH Q2 (R1)), the analytical approachwassuccessfully validated. By using the gradient method of acetonitrile and buffer, the peak of ACB and ERDwasfound to be at 5.47, 7.96 and 3.41 min, respectively. ACB and ERD showed linear response from 50-150 µg/mLandfrom 150 -450 µg/mL, with correlation coefficient (R 2) as 0.9997 and 0.9995, respectively. The percentage recoveryfor ACB and ERD was also determined to be 99.1–102.2% and 99.6–101.7%, respectively, falling well withintherange of 98–102.2%. The current approach was found to be precise, accurate, robust and could be beneficiallyutilised for the concurrent analysis of ACB and ERD in dosage form.

Keywords: Acebrophylline, Erdosteine, RP HPLC, Validation, Simultaneous Estimation






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