Abstract

Validated UV Spectrophotometric area under curve Method for Determina-tion of Formoterol Fumarate Dihydrate in Bulk and Pharmaceutical Formula-tion using Hydrotropic Solubilization Technique

Author(s): Aashish SP, Sandip DF and Sanjay JS

A novel, safe, accurate, sensitive and economic two UV-Spectrophotometric methods “Method A” zero order and “Method B” Area under curve (AUC) was developed by the application of hydrotropic solubilization technique using 1% ammonium acetate solution as hydrotropic solubilizing agent for the quantitative determination of poorly water-soluble Formoterol Fumarate Dihydrate (FFD) from bulk and tablet dosage form. The solubility of FFD increases hydrotropic solution as compared to solubility in distilled water, thus, 1% ammonium acetate hydrotropic solution was employed to carry out UV-spectrophotometric analysis precluding use of organic solvents. FFD obeyed Lambert Beer’s law in the concentration range of 10 to 60μg/mL (r2=0.999) for both methods in hydrotropic agent with mean recovery was found 99.23 ± 0.83% (Method A) and 99.42 ± 0.42 for (Method B). The percent concentration in marketed tablet formulation was found 99.60 ± 0.78% (Method A) and 99.69 ± 1.07% (Method B). Parameters such as linearity, precision, accuracy, specificity and ruggedness were studied as reported in the International Conference on Harmonization guidelines. The relative standard deviations for three replicate measurements in six concentrations of samples were always less than 2%. So this method can successfully employ in the routine analysis of FFD in bulk drug and pharmaceutical formulation