Stability Indicating Rp-Hplc Method For The Estimation Of Drug In Marketed Formulation

Abstract

The aim and objective of the present work has been to develop new simple, sensitive and validated RP-HPLC method for the estimation of drugs in marketed formulation. Validation of developed Analytical methods according to ICH guidelines. Stress study was performed on Deflazacort and was found that it degrade sufficiently in acidic, alkaline and oxidative condition but less degradation was found in thermal and photolytic oxidation the % of degradation of active constituents was found to be 16.64%, 10.25 %and 8.67% respectively. The analysis was carried out on waters HPLC. It has 715 binary pumps, Rheodyne injector with a 20-microlitre loop, U.V. Vis. Detector, Thermo C-18 column (4.6 x 250mm, 5μ particle size) with data ace software. and the mobile Phase composition was  water -methanol ratio 80:20 flow rate 1ml/min, methanol-water ratio 70:30 flow rate 1.2 ml/min, acetonitrile-water ratio 40:60  flow rate 1.2ml/ min and methanol - acetonitrile ratio 50:50 fl0w rate 1ml/min at room temperature  and most suitable . The sample injection volume was 20 uL, and eluents of the isocratic elution mode were monitored at 241nm. The retention time was 5.25 min. The method was linear in the concentration range of 5-25 ug/ml with an 16.14 r2=0.999. The LOD and LOQ were found to 0.82ug/mL and 2.41ug/mL of Deflazacort.