Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ASSAY OF RANOLAZINE EXTENDED RELEASE TABLETS

N. Jayasimha*, V .Krishna Reddy, Tadepalli Pravallika, E. Sasi Kiran Goud

ABSTRACT

A simple, sensitive and accurate isocratic reverse phase high performance liquid chromatography method was developed for determination of ranolazine in tablets. The effective separation was achieved on Thermo, Hypersil BDS C8, 250 x 4.6 mm, and 5μm. The mixture of buffer and acetonitrie in the ratio 50: 50v/v used as a mobile phase. The buffer was prepared as 1.93 g of ammonium acetate in 1000 ml of purified water and adjusts the pH 5.5 with diluted acetic acid. The flow rate of the mobile phase was 1.0 mL/min and the total elution time was 9 minutes. The UV detection wavelength was carried at 220 nm and experiments were conducted at 30°C. The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy, limits of detection and quantification for the impurities following the ICH guidelines.

Keywords: Ranolazine, Method development, Hypersil BDS C8 and RP-HPLC.


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