VALIDATED SPECTROPHOTOMETRIC METHOD FOR THE QUANTITATION OF URSODIOL IN BULK AND TABLET DOSAGE FORM

Karthik N.R.*, Sowmya H.G. and Jose Gnana Babu C.

ABSTRACT

Simple, precise and accurate zero order derivative spectroscopic method has been developed and validated for the estimation of Ursodiol (Ursodeoxycholic acid) in bulk and pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 240nm in Methanol: Acetonitrile: O-Phosphoric acid (40:40:20) solution and obeys Beer’s law in the concentration range of 2-10μg/ml. The linearity study was carried out and regression coefficient was found to be 0.9998=b and it has showed good linearity, precision during this concentration range. The % recovery was found to be 98.50-100.66. The LOD and LOQ were found to be 0.023 and 0.07μg/ml. The percentage relative standard deviation is found to be less than 2. According to ICH guidelines the technique has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for routine quantification of Ursodiol in bulk and pharmaceutical dosage form.

Keywords: Ursodiol, zero order derivative spectroscopy, validation, pharmaceutical formulations.