Validation of Uplc-Ms/Ms Method for the Content of Mp-Epoxy Propane in Ranolazine Drug Substance

Abstract

A LC-MS/MS method was developed for determination of MP-Epoxypropane using Hypersil BDS C18 column (125 x 4.6 mm, 3.5 µm) and a mobile phase of 0.2% formic acid in water as mobile phase A, and 0.02M Ammonium formate in water as mobile phase B and acetonitrile as mobile phase C in gradient elution mode at 0.4 mL/min flow rate with MS detector. The mass of MP-Epoxypropane  was found 180 in ESI positive mode and the retention time was found 6.11 minutes. The proposed method was validated for System suitability, Specificity, Linearity, LOD and LOQ, Recovery, Precision, and Range. All the parameters were found within the acceptable limits. Linearity of MP-Epoxypropane was in the range of LOQ to 150% of specification level. LC-MS/MS method was specific, accurate, precise and suitable for the analysis of MP-Epoxypropane in Ranolazine drug substance.