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Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ATOVAQUONE AND PROGUANIL HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

Sharanya M., Hafsa Siddiqua*, Dr. Sunil Kumar Chaitanya Padavala and Rubina Kauser

ABSTRACT

A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for simultaneous determination of Atovaquone and Proguanil HCL in pure form and marketed combined pharmaceutical dosage forms. A column having Phenomenex Luna (C18) (250mm x 4.6mm, 5μm) in isocratic mode with mobile phase containing Methanol: Water (65:35 v/v) was used. The flow rate was 1.0 ml/min and effluent was monitored at 220 nm. The retention time (min) and linearity range (ppm) for Atovaquone and Proguanil HCL were found to be (3.202, 5.463min) and (30-70, 10-50), respectively. The proposed method has been validated for linearity, accuracy and precision, robustness and limit of detection and limit of quantification. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 2.6μg/ml and 7.8μg/ml for Atovaquoneand 3.4μg/ml 10.2μg/ml for Proguanil HCL respectively. The percentage recovery of Atovaquone and Proguanil HCL was found to be 100.187% and 100.748% respectively. The developed method was found to be accurate, precise and selective for simultaneous determination of Atovaquone and Proguanil HCL in pure form and marketed combined pharmaceutical dosage forms.

Keywords: Atovaquone and Proguanil HCL, RP-HPLC, Validation, Accuracy, Precision.


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