Abstract

DEVELOPMENT AND VALIDATION OF A SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF DARUNAVIR ETHANOLATE BOTH IN BULK AND MARKETED DOSAGE FORMULATIONS

Gholve Sachin B.*, Asware Baburao S., Kadam Shrihari C., Bhusnure Omprakash G. and Thonte Sanjay S.

Abstract

A simple, rapid, specific and cost effective spectrophotometric method has been developed using a solvent composed of Methanol: Acetonitrile: Water (60:30:10) to determine the Darunavir Ethanolate (DRV) content in bulk and pharmaceutical dosage formulations. A premax of 267nm, it was proved linear and obeys beer’s law in the concentration range of 2 to 12μg/ml, and exhibited good correlation coefficient (R2=0.991). The validity of the described procedure was assessed. Statistical analysis of the result has been carried out revealing high accuracy and good precision. The proposed method was successfully applied to the determination of DRV in pharmaceutical formulations without any interference from common excipients. This method was successfully applied to the determination of DRV content marketed brand the results were in good agreement with the label claims. The obtained results proved the method can be employed for the routine analysis of DRV in bulk as well as in the commercial formulations.

Keywords: Darunavir Ethanolate; UV spectrophotometry; Validation