Analytical Method for Simultaneous Estimation of Ranolazine and Metformin Hydrochloride by Validated RP-HPLC-DAD Method:(TJPS-2020-0258.R3)

Abstract

In the present study, a simple, sensitive, rapid, accurate, and precise RP-HPLC method with diode array detection was developed and validated for simultaneous estimation of Metformin hydrochloride and Ranolazine in a synthetic mixture. The method was developed by using isocratic elution mode on a reversed-phase. Chromatographic separation was performed on ACE CN C18 (250 mm, 4.5 mm, 5 μm) column and a mobile phase consisting of methanol: acetonitrile: ammonium formate (45:45:10% v/v/v) with 10% formic acid to adjust the pH to 6.0, at a flow rate of 1.0 ml/min. detection and quantification of all the analytes were carried out at 230 nm by using a photodiode array detector. The method was found to be linear in the range of 1-50 μg/ml for Ranolazine and 2 -100 μg/ml for Metformin hydrochloride. Percentage recovery was found in the range of 99.07-101.53% for Ranolazine and 99.59-100.45% for Metformin hydrochloride. The RSD of precision and repeatability was found lower than 1% for each drug. Validation of the method was carried out as per International Council on Harmonization (ICH) guideline Q2 (R1). The proposed RP-HPLC method can be highly suitable for the analysis of Ranolazine and Metformin hydrochloride without interference.