& A rapid, simple, sensitive, and selective reverse phase gradient UPLC method has been developed for separation and determination of 2-((2-Methoxy phenoxy) methyl) oxirane (RN), its regio isomers, and process related impurities, which is an intermediate of Ranolazine pure form. The separation was achieved on a reversed phase RP-18 column using Water as solution A and Acetonitrile, Water mixture (70:30 v=v) as solution B in a gradient elution at 0.3 mL=min À1 flow rate with UV detection at 223 nm. The method is found to be selective, precise, linear, accurate, and also robust. It was used for not only quality control, but also monitoring the synthetic reactions involved in the process development of Ranolazine. The LC method is found to be simple, rapid, specific, and reliable for the determination of unreacted raw materials and isomers in reaction mixtures and finished product Ranolazine. The method was completely validated as per ICH guidelines and results from validation confirmation that the method is highly suitable for its intended purpose.
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