Abstract

A rapid novel RP- HPLC stability indicating assay method development and validation of dipyridamole in dipyridamole extended release capsules

Author(s): D.Vivekananda Reddy, P.Sreelatha, B.Rama Devi

Asimple, rapid and sensitive RP-HPLCmethodwas developed and validated for the quantification of Dipyridamole in bulk drug and tablet formulation. The separation was achieved on a Inertsil X-terra MS C 18 (100 x 4.6 mm, 3.5ìm). The mobile phase containing a gradient mixture of mobile phaseA(1.0 g Potassium dihydrogen phosphate buffer, pH adjusted to 7.0 with 5% sodium hydroxide solution and Methanol in the ratio of 40:60 v/v) and mobile phase B (1.0 g Potassium dihydrogen phosphate buffer, pH adjusted to 7.0 with 5%sodiumhydroxide solution andMethanol in the ratio of 5:95 v/v).At a flow rate of 1.5 mL min-1 and detection was performed at 282 nm using photodiode array (PDA) detector. The drug was subjected to various ICH prescribed stress conditions including hydrolysis (neutral, acid and alkaline), oxidation, photolysis and thermal degradation. The drug in solution was found to degrade significantly in alkaline hydrolysis and when exposed to sunlight. The proposed method was validated with respect to specificity, linearity, accuracy, precision, stability, ruggedness and robustness as per ICH guideline. The peak purity achieved fromPDAdetector and satisfactory Separations between drug and its degradants established the specificity of the method. The developed method was found to be successively applied for the quality control of Dipyridamol in bulk drug and tablets as well as the stability studies.