Abstract

SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ATOVAQUONE AND APROGUANIL IN TABLET DOSAGE FORM

Nitin S. Jadhav*, K.G. Lalitha

ABSTRACT

A novel combination of Atovaquone and Proguanil is used in the treatment of Pneumocystis Pneumonia, toxoplasmosis and for chemoprophylaxis of malaria. A simple, economic, sensitive, accurate and reproducible spectroscopic method has been developed and validated for the simultaneous estimation of Atovaquone and Proguanil in tablet dosage form by Simultaneous equation method. Atovaquone and Proguanil were found to have absorbance maxima at 279 and 254 nm respectively in distilled water. Atovaquone was found to be linear in the concentration range of 7.5 to 20 μg/ ml at 279 nm and Proguanil was found to be linear in the concentration range of 3 to 8 μg/ml at 254 nm. The LOD and LOQ were found to be 15.20 μg/ml and 46.08μg/ml (at 279nm) for Atovaquone and 6.31μg/ml and 19.12μg/ml at (254nm) for Proguanil respectively. The recovery of Atovaquone and Proguanil were found to be 100.36% and 99.41% respectively showing accuracy of the method. The method was validated statistically as per ICH guidelines. The method showed good reproducibility and recovery with % RSD less than 2. So, the proposed method was found to be simple, specific, precise, accuracy, linear, and economical. Hence it can be applied for routine analysis of Atovaquone and Proguanil in pharmaceutical formulations.

Keywords: Atovaquone and Proguanil, Simultaneous euation method, Validation, ICH.