Abstract

Method Development and Validation of 2-[(2-Methoxyphenoxy) Methyl] Oxirane Content in Ranolazine Drug Substance by LC-MS/MS

Rahul Dev* and Rahul Kumar

Department of Chemistry, ShriVenkateshwara University, Gajraula, Amroha (Uttar Pradesh), INDIA.

ABSTRACT

A LC-MS/MS method was developed for determination of 2-[(2- methoxyphenoxy) - methyl] oxirane using Xselect CSH ® C18 (100 x 3.0) mm, 2.5μm and a mobile phase of buffer pH 5.50 : Methanol with gradient, at flow rate of 0.3 ml/min with MS detector. The mass of 2-[(2-methoxyphenoxy) - methyl] oxirane was found 181.17 in ESI positive mode and the retention time was found 4.9 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 2-[(2-methoxy phenoxy) - methyl] oxirane 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 2-[(2-methoxy phenoxy) - methyl] oxirane in Ranolazine drug substance.

Keywords :Liquid chromatography with mass spectrometry (LC-MS/MS), Genotoxic impurity, ICH guideline and Method Validation.