Abstract

SIMULTANEOUS ESTIMATION AND VALIDATION OF KETOCONAZOLE AND SALICYLIC ACID IN BULK AND EMULGEL FORMULATION BY SPECTROPHOTOMETRIC METHODS

Deepali M. Nahar*, Melroy M. D’Sa, Ramesh D. Bhusal and Mrunmai C. Raut

Abstract

Two simple and economic UV Visible spectrophotometric methods have been validated for the determination of Ketoconazole and Salicylic acid in bulk and emulgel formulation. The developed emulgel containing Ketoconazole and Salicylic acid was formulated for the management of Psoriasis. Quantitation was carried out by two spectrophotometric methods such as Simultaneous equation method and Absorbance ratio method. The wavelength selected for Simultaneous equation method were 225 nm (λmax of ketoconazole) and 296 nm (λmax of salicylic acid). In Absorbance ratio method, two wavelength 296 nm, λmax of Salicylic acid as λ2 and 239 nm, isoabsorptive point as λ1 was selected. Both the method follows beer’s linearity in the range of 3-21 μg/ml for Ketoconazole and 3-21 μg/ml for Salicylic acid with correlation coefficient value (r2) for both the drug being more than 0.995. According to ICH guidelines the parameters Linearity, Precision, Accuracy, Limit of detection, Limit of quantification, Robustness, Ruggedness was performed. Result of analysis were validated statistically. All the validation parameters were found to be within limit of acceptance.

Keywords: Emulgel, Ketoconazole, Salicylic acid, Psoriasis, Simultaneous Equation Method, Q-Absorption Ratio Method, Validation.