Abstract

STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ATOVAQUONE AND PROGUANIL IN BULK AND TABLET DOSAGE FORM

S. Naazneen* and A. Sridevi

Abstract

The present work aimed to develop a stability indicating high Performance Liquid Chromatographic (HPLC) validated method for the cestimation of combined tablet formulation of Atovaquone and Proguanil Hydrochloride. Chromatographic separation was optimized by gradient HPLC on a C18 column [Inertsil Silica, 250 x 4.6 mm, 5μ] utilizing a mobile phase consisting a mixture of 10mM ammonium formate, pH 3.5 and 90:10 v/v acetonitrile - methanol in the ratio of 30:70 v/v at a flow rate of 0.9ml/min with UV detection at 254nm. The retention time of Atovaquone and Proguanil Hydrochloride was 7.3 min and 3.8 min respectively. The developed method was validated as per ICH guidelines. Linearity of the method was good over the concentration range 2.5μg/ml to 20μg/ml for proguanil and 6.25-50 μg/ml for atovaquone. Correlation coefficient was found to be 0.999&0.999 for proguanil & Atovaquone respectively. The % mean recovery of proguanil (98.38-101.09.%) & atovaquone (98.62-100.99%) at each level was within the limits of 98% and 102%.The results obtained for accuracy, precision, LOD, LOQ and Ruggedness were within the limits. Thus the validated economical method was applied for forced degradation study of Atovaquone and Proguanil Hydrochloride tablet.

Keywords: Atovaquone and proguanil, stress study, HPLC method.