New validated ultra high performance liquid chromatographic method for estimation of Ranolazine hydrochloride

In present work attempt has been made to develop and validate new Ultra High Performance Liquid Chromatographic (UHPLC) method for estimation of Ranolazine hydrochloride. A simple, selective, specific and precise UHPLC method was developed for estimation of Ranolazine Hydrochloride in bulk powder. Method was developed by using mobile phase composition Methanol: 0.1% Orthophosphoric Acid (50:50 v/v) and the separation were achieved using BDS Hypersil C18 (250mm x 4.6mm, 5µm) column. The flow rate was adjusted to 1.5 ml/min and the temperature was maintained at 200 C. UV detection was monitored at 224 nm. The volume of the sample injected was 10 µl. The retention time of Ranolazine was found to be at 8.9 min. It showed linear response between the concentration ranges of 20-100 µg/ml with correlation coefficient was found to be 0.999. The method was validated for accuracy, precision, robustness as per the ICH Guidelines and all the values of validation was found to be within the acceptance. A new UHPLC method was developed for estimation of Ranolazine and it was validated as per ICH Guidelines. Hence it can be concluded that method was new, simple, selective, specific, precise and found to be economic for estimation of Ranolazine in bulk powder.