DEVELOPMENT AND VALIDATION OF DIFFERENCE SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF TENOFOVIR DISOPROXIL FUMARATE IN ITS PURE AND PHARMACEUTICAL DOSAGE FORM

*Swapna A. S., Hassan Mohammed S., Fathimath Hasna P. P., Dr. Sheeja Velayudhan Kutty, Dr. C. Karuppasamy and Jeeva A. S.

ABSTRACT

A simple, precise and accurate difference spectroscopic method has been developed for the estimation of tenofovir disoproxil fumarate in its pure and pharmaceutical dosage form. In two sets of 10 ml volumetric flask, aliquots of standard drug solution in distilled water were transferred and diluted the first set with 0.01M sodium hydroxide and other set with 0.01M hydrochloric acid to get a concentration of 10-50 μg/ml for both the sets. The difference in absorbance of tenofovir disoproxil fumarate at 239 nm (maxima) and 224 nm (minima) was calculated. Beer’s law is obeyed in the concentration range of 10-50 μg/ml with a linear regression value 0.998. As per ICH guidelines the results of the analysis were validated statistically and were found to be satisfactory. Recoveries obtained do not differ significantly from 100% showed that there was no interference from the common excipients used in the tablet formulation indicating accuracy and reliability of the method. The limit of detection and limit of quantification were found to be respectively.

Keywords: Tenofovir disoproxil fumarate, UV visible spectrophotometer, Difference spectrophotometry, Hydrochloric acid, Sodium Hydroxide.