Spectrophotometric Methods for Determination of Ethamsylate in the Presence of its Degradation Product Hydroquinone

Ethamsylate was determined in the presence of its known degradation product, hydroquinone, as an impurity using spectrophotometric methods. Four spectrophotometric methods: second derivative, derivative ratio, ratio difference, and dual wavelength, were evaluated. The accuracy, precision, and linear range were determined for each method, and the methods were validated as per ICH guidelines. The specificity of each method was assessed by analyzing synthetic mixtures containing different proportions of the degradation product and drug. The developed methods were applied to the determination of ethamsylate in bulk powder and two dosage forms.