ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF PYRANTEL PAMOATE AND FEBANTEL IN AN ORAL DOSAGE FORM BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)Abstract
The present manuscript describes a new simple, specific, precise and accurate RP-HPLC development and subsequent validation for simultaneous estimation of Pyrantel pamoate and Febantel in their combined dosage form. The proposed method involves the utilization of a hypersil BDS C18 (150 × 4.6 mm, 5 µ) column, mobile phase containing acetonitrile: phosphate buffer in the ratio 85:15% v/v and 55:45% v/v with apparent pH adjusted and maintained to 3.5 using 0.01M orthophosphoric acid, pumped at a flow rate of 1.0 ml/min. The injection volume was 20 µl, and detection was monitored at 286 nm. The components were eluted by gradient mode. The peaks obtained were sharp and well resolved with retention times 4.5 min (Pyrantel pamoate) and 6.5 min (Febantel). The calibration curves were linear (r2=0.999) over the concentration range of 25-150 µg/mL for Pyrantel pamoate and Febantel both. Validations of the proposed method were carried out for its accuracy, precision, linearity, robustness LOD and LOQ according to ICH Q2 R1 guidelines. The statistical analysis was carried out and the results of which were found satisfactory. Based on results, the developed method could be used for routine estimation Pyrantel pamoate and Febantel in the marketed formulation.
J. S. Tople *, A. Sherje and R. Mallya
Department of Quality Assurance, Dr. Bhanuben Nanavati College of Pharmacy, Vile Parle (West), Mumbai, Maharashtra, India.
21 July 2018
28 September 2018
01 October 2018
01 April 2019