Tue, 21 Nov 2017

Development and Validation of RP-HPLC Method for Simultaneous Determination of Ranolazine In Bulk and Pharmaceutical Dosage Form

Farhana Sharmin1*, Mariyam Akter1, Jasmin Ara Nipa1

1.Department of Pharmacy, Noakhali Science and Technology University, Sonapur, Noakhali-3814, Bangladesh


ABSTRACT

This present study was undertaken with an objective to develop & validate a simple, precise, cost effective, sensitive & fast RP- HPLC method for the analysis of Ranolazine. A Shimazu HPLC system with Luna 5µm C18 is employed for the analysis using Methanol: Acetonitrile(50:50, v/v) as mobile phase. Signal from Ranolazine is detected at 227nm by UV Spectrophotometer. The total retention time was 5 min with a flow rate of 1.0 ml/min. % 0f RSD values for precision is found to be 0.798%.The limits of detection (LOD) and quantification (LOQ) were 0.616 and 1.86, respectively. As per ICH guidelines the proposed method is fully validated and found to be linear over a workable drug concentration, accurate, precise and robust. This fast, simple and inexpensive method is suitable for research laboratories & also for quality control analysis in pharmaceutical industries.

Keywords: Ranolazine, RP-HPLC, Acetonitrile, Linearity, Validation.


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