DEVELOPMENT AND VALIDATION OF A DISSOLUTION TEST FOR URSODEOXYCHOLIC ACID AND TAURINE FROM COMBINED FORMULATION

• Main Authors: OLENA I. GOLEMBIOVSKA 1, 2, ALEXANDER YU. GALKIN 3, 4*, ALEXANDER B. BESARAB 4
• Format: Article
• Language: English
• Published: Alma Mater Publishing House "Vasile Alecsandri" University of Bacau 2019-10-01
• Series: Scientific Study & Research: Chemistry & Chemical Engineering, Biotechnology, Food Industry
• Subjects: dissolution test; HPLC; ursodeoxycholic acid; taurine; validation
• Online Access: http://pubs.ub.ro/?pg=revues&rev=cscc6&num=201903&vol=3&aid=4935

The objective of the work was to establish experimental conditions for the dissolution test for ursodeoxycholic acid (UDCA) and taurine in tablet dosage form (artichoke leaf extract, UDCA, taurine, and Angelica sinensis roots extract) and to validate the dissolution test for specificity, precision, linearity and range, accuracy, and robustness. A fast and robust method applicable for quantification of the four compounds was developed and validated according to International Council for Harmonisation (ICH) guidelines. A dissolution test for the UDCA-taurine combined formulation was developed and validated, using a suitable High-Performance Liquid Chromatography (HPLC) and titration method for simultaneously quantitation both dissolved substances. The optimized conditions include the use of USP apparatus 2 at a paddle rotation rate of 75 rpm and 900 mL of water as dissolution medium, at 37.0 ± 0.5 °C. The HPLC quantitation method for UDCA and titration for taurine was also adapted and validated. The both methods developed in this study showed specificity and selectivity with linearity (r = 0.9995) in the working range (50 - 130 %) and good precision and accuracy.