Development and validation of analytical methods for the estimation of trioxsalen in pharmaceutical dosage form by using uv-spectrophotometry and HPTLC

Abstract

Analytical monitoring of a pharmaceutical product or of specific ingredients within the product is necessary to ensure its safety efficacy throughout all phases of its shelf life. Such monitoring is in accordance with the specifications elaborated during product development. Analytical validation is the corner stone of process validation without a proven measurement system it is impossible to confirm whether the manufacturing process has done what it purports to do. All new methods developed are validated. Determination of Trioxsalen in a fixed dosage form was carried out by UV Spectrophotometric and HPTLC method. The absorbance values were observed for different dilutions of drug at 248 nm and which are used for the dilution in Ethanol. This method obeys Beer’s Lambert’s Law in the concentration range of 1-5µg/ml. The results have been validated statistically and the recovery studies confirmed the accuracy of this proposed method.