Analytical method development and validation for the estimation of ursodiol in bulk and pharmaceutical formulation by RP-HPLC

Abstract

The present work is aimed at developing and validating an accurate, precise and rapid high -pressure liquid chromatography method (HPLC) for the estimation of ursodiol in bulk and pharmaceutical formulation. The separation was achieved using RP C-18 XTerra Column (25 cm x 4.6 mmx5 µm) and mobile phase comprising of  methanol: acetonitrile: phosphoric acid  (60:20:20 v/v). The  flow rate  maintained at  0.8  ml/min  with  a minimal run time of 7 minutes. The retention time of ursodiol was found to be 3.085 minutes. T his method is linear over the range of 2-24 μg/ml with a recovery of 99.54%.The regression equation is 54219.86x + 7662.85 with regression coefficient of 0.999. Validation parameters such as specificity, linearity, precision, accuracy, robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to  the  International  Conference  on  Harmonization  (ICH)  Q2  R1  guidelines.  The  method  fulfilled  the requirements for reliability and feasibility for application to the q uantitative analysis of ursodiol in bulk and pharmaceutical dosage forms.