Abstract

A VALIDATED STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT FOR SIMULTANEOUS DETEMNINATION OF ATOVAQUONE AND PROGUANIL IN PHARMACEUTICAL FORMULATION

R. N. Patil, Kalyan P. Pise*, Mangesh Harole and Govind Suryawanshi

ABSTRACT

A simple, accurate, precise method was developed for simultaneous estimation of the Atovaquone and Proguanil in tablet dosage form. Chromatogram was run through BDS C 18 (150 4.6 mm 5) Mobile phase containing Buffer and Acetonitrile in the ratio of 55:45 v/v with a flow rate of 1.0 ml/min for developing method. Temperature was mainted at 30 C. Retention time of Atovaquone and Proguanil were found to be 2.48 min. and 3.35 min. % RSD of the Atovaquone and Proguanil were found to be 0.91 and 0.81 respectively. Limit of detection and Limit of quantification values were obtained from regression equations of Atovaquone and Proguanil were 0.32 ppm, 0.98 ppm and 0.55 ppm 1.67 ppm. Regression equation of Atovaquone is y = 11372+1378 and of Proguanil is y=5184+2457. The method was validated statistically as per ICH guideline. % recovery were obtained as 100.37 for Atovaquone and 100.18 for Proguanil. The high percentage of recovery indicate the proposed method is highly accurate. The method showed good reproducibility and recovery. So the proposed method was found to be simple, precise, linear, specific and economical. Hence it can be applied for analysis of Atovaquone and Proguanil in pharmaceutical formulation.

Keywords: RP-HPLC, Atovaquone, Proguanil, Validation.