Quantification and stability aspects of Luliconazole in bulk and pharmaceutical dosage forms by UV spectroscopy

Abstract

Two simple and economical UV spectroscopic methods were developed for the estimation of Luliconazole in creams. The drug showed maximum absorption at 294 nm, both in 0.1N HCl and phosphate buffer (pH 2.0) in the fundamental spectra (D0). The same spectra were derivatized into first derivative (D1) and the dA/dλ was measured at 315 nm in 0.1N HCl and 317 nm in phosphate buffer (pH 2.0). In both the methods the drug obeyed Beer-Lambert’s law in the concentration range of 2-30 μg/mL in 0.1N HCl and 10-30 μg/mL in phosphate buffer (pH 2.0). The linear regression equations were calculated to be y = 0.0504x + 0.0102 (R2 = 0.9991) for D0 and y = 0.0025x + 0.0002 (R2 = 0.9991) for D1 in 0.1N HCl, y = 0.0637x + 0.0181 (R2 = 0.999) for D0 and y = 0.0025x + 0.0006 (R2 = 0.999) for D1 in phosphate buffer (pH 2.0). An acceptable recovery in the range of 98 ± 0.01 – 102 ± 0.001 % indicates accuracy as well as non-interference from excipients in the present method. The intraday and inter day precision results were within 2 % RSD indicating the preciseness of the methods. The methods were applied for quantification of Luliconazole in marketed creams and the assay was obtained as 98.53 % w/w against the label claim. The methods were also applied to study the stability aspects of the drug in a variety of conditions like acid, base and oxidative stress along with thermal and photolytic stress conditions. The drug showed altered absorbance in basic and photolysis conditions. The methods were validated statistically as per the ICH guidelines. Keywords: Luliconazole, UV spectroscopy, Stability, Validation, ICH.