Abstract
SIMULTANEOUS DETERMINATION OF NICORANDIL IN PHARMACEUTICAL DOSGAE FORM BY HPLC METHOD

Prof. Dr. Mounir Zaky, Prof. Dr. Alaa Amin, Dr. Hanaa khater, Dr. Emad Mahmoud Abd El-Halim*

ABSTRACT

A rapid and accurate HPLC method was developed for determination of Nicorandil in tablet dosage form. The chromatographic separation was conducted on Agilent 1200 with DA detector; using BDS column; ACE, (150 x 4.6 mm, 5 μm). The mobile phase was isocratic consisted of Methanol: Phosphate buffer in ratio of (30: 70 v/v) (buffer is composed of 6.8 gm potassium dihydrogen phosphate per liter and was delivered to the system at a flow rate of 1 ml/min. An injection volume of 20 μl . The detection wavelength (λ max) was 262 nm. All assays were performed at ambient conditions. The calibration curve in mobile phase was linear with correlation coefficient (r2) = 0.99999; over a concentration range of 5 – 20 mcg/ ml with a retention time of 3.19 minutes. . The percentage recoveries of Nicorandil were 99.84% to 101.71%; respectively. The relative standard deviation (RSD) was found to be 1.06% The proposed method was validated and successfully applied for simultaneous determination of Nicorandil in tablets. The method described is quite suitable for routine analysis of tablets and for their dissolution quantitation.

Keywords: Nicorandil; HPLC; BDS column; Method Validation.


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