Journal of Pharmacovigilance

Development of HPLC-UV/MS-MS methods applied to the quality control of Ursodeoxycholic acid in oral liquid pediatric formulations and raw material

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Boscolo O, Flor S, Martinefski M, Buontempo F, Tripodi V and Lucangioli S

University of Buenos Aires, Argentina

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

Ursodeoxycholic acid (UDCA), is a bile acid used to dissolve gallstones and for the treatment of hepatobiliary diseases. It is the only drug approved by the FDA for the treatment of primary biliary cirrhosis. In UDCA, raw material or other bile acids may be present as impurities. Some of them, like lithocholic acid (LCA) are highly toxic and others are associated with several side effects such as chenodeoxycholic acid (CDCA). USP (United States Pharmacopeia) describes the determination of CDCA and LCA by TLC, where each impurity limit should be not more than 1.5% and 0.02% respectively. The aim of this work was to develop and validated an analytical method by HPLC-UV for the determination of UDCA in oral liquid pharmaceutical formulations for pediatrics administration. Also, the impurities present in the raw material were determined by HPLC / MS-MS. HPLC-UV system was applied to a C18 Symmetry column (150 mm x 4.6 mm ID, particle size 3.5 μm, Water), mobile phase ACN:H2O pH 3 (48:52), column temperature 40° C, flow rate 1 mL/min, injection volume 100 μL and detection UV 200 nm. In the determination of impurities the chromatography method was carried isocratically at 25°C, using a column C18 Symmetry, mobile phase methanol:acetonitrile:10mM ammonium acetate buffer (40:40:20) and flow rate 0.4 mL/min. Negative polarity and SRM mode were set for MS detection. The parameters optimized were: Voltage, sheath gas pressure and turbulence offset. Both methods were validated in terms of specificity, LOD (Limit of Detection), LOQ (Limit of Quantification), linearity, precision, accuracy and robustness. The developed methods meet specifications and are suitable for quality control.

Biography :

Boscolo O is a 6 course graduate who recently finished his third year Doctoral Scholarship from the University of Buenos Aires in “Galenic and Analytical Development of Orphan Formulations Applied to Ursodeoxycholic acid Therapy in Children”. He worked as Assistant in Laboratory Technique, Researcher at the Centre for Research Development and Pharmaceutical Control at CIDEC and Grade Teacher as an Assistant with exclusive responsibility at Pharmaceutical Technology Department. He has 2 publications in international journals, 3 published abstracts, 7 presentations at scientific congresses, 1 unit in book chapter, and a participant in 3 congresses.

Email: slucangi@live.com.ar oriboscolo@hotmail.com