Determination of ursodeoxycholic acid in pharmaceutical preparations by capillary electrophoresis with indirect UV detection.
A simple and rapid capillary electrophoretic method, with indirect UV detection, for the quantification of ursodeoxycholic acid (UDCA) in pharmaceutical preparations was developed in this study. Sodium p-hydroxy benzoate was used as background electrolyte (BGE) (5 mM, pH 8.0) and visualization agent. Separation was carried out on a fused-silica capillary (50 microm x 72 cm) at a potential of 25 kV under ambient temperature and detected at 250 nm. Glycocholic acid was used as internal standard for quantification. Both run-to-run repeatability and day-to-day reproducibility of migration time were below 0.1% relative standard deviation (R.S.D.). Repeatability and reproducibility of relative peak height were 3.3 and 3.8% R.S.D., respectively. Accuracy was tested by spiking two pharmaceutical tablets with standards and the recoveries were 101.9+/-9.87 and 99.6+/-9.60% (n=3), respectively. Linearity of relative peak height was tested in the range 20-100 microg/ml. Limit of detection (LOD) was 3 microg/ml. The method could be used to assay UDCA raw materials and formulation products.
Chang
Hsing-Yun
HY
School of Pharmacy, College of Medicine, National Taiwan University, 1, Section 1, Jen-Ai Road, Taipei, Taiwan.
Kuo
Ching-Hua
CH
Sun
Shao-Wen
SW
D019075:Electrophoresis, Capillary / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013678:Technology, Pharmaceutical / Q000379:methods*; D014580:Ursodeoxycholic Acid / Q000032:analysis* / Q000737:chemistry
D004364:Pharmaceutical Preparations; D014580:Ursodeoxycholic Acid