Description:
Ursodeoxycholic acid is an active compound to treat cholesterol gallstones and included in Biopharmaceutical Classification System c lass II. Ursodeoxycholic a cid c apsule f ormulations have been developed by the pharmaceutical industries. Due to requirement, assay and dissolution tests need to be routinely carried out to control quality of the drug. Therefore, aim of this study was to develop a simultaneously analytical method for assay and dissolution test. Optimum condition of analysis were using HPLC-RID, C18 column (5 µm; 3.9 x 300 mm), acetonitrile:phosphate buffer pH 3.0 (55:45 v/v) as mobile phase with flow rate 1 mL/min, 50 µL injection volume, column, detector, and sample temperature were set at 40 oC. This method provides good linearity in a range of 50- 130 % concentration for assay and dissolution test with correlation coefficient values of 1 and 0.999. respectively. LOD and LOQ for assay were of 4.892 µg/mL and 14.824 µg/mL whereas for dissolution tests of 6.501 µg/mL and 19.701 µg/mL. The average percent recovery for assay and dissolution test were in a range of 100.018±0.888% and 98.936±2.124 %. Repeatability and intermediate precision of assay were obtained by determining RSD values of 0.466% and 0.279-0.483 %, while the dissolution test were 1.137% and 0.032-0.289 %

URL:
http://103.158.96.210:88/web_repository/uploads/31420-132340-1-PB.pdf

Type:
Journal

Document:
Diploma III Farmasi

Date:
23-06-2024

Author:
WANTI MEGAWATI