Optimization of RP-HPLC method with UV detection for determination of ursodeoxycholic acid in pharmaceutical formulations

Author:

Poposka Svirkova Zhaklina1,Arsova-Sarafinovska Zorica1,Grozdanova Aleksandra2

Affiliation:

1. Institute for Public Health of the Republic of North Macedonia, St. 50 Division No.6, 1000 Skopje, Republic of North Macedonia

2. Instute of Pharmaceutical Chemistry, Faculty of Pharmacy, Ss. Cyril and Methodius University, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia

Abstract

Due to the low absorptivity of bile acids, the aim of this study was to develop and validate a simple and sensitive HPLC/UV method for quantification of ursodeoxycholic acid (UDCA) in pharmaceutical formulations. Effective separation was achieved on C18 end–capped column, with gradient elution of a mobile phase composed of 0.001 M phosphate buffer (pH 2.8±0.5) – acetonitrile mix, at flow rate 1.5 mL min-1, UV detection at 200 nm and injection volumes were 50 µL. The proposed HPLC method was fully validated according to the ICH guidelines and it was found to be simple, accurate, precise and robust. Key words: ursodeoxycholic acid, HPLC/UV, pharmaceutical formulations, validation

Publisher

Macedonian Pharmaceutical Association

Subject

General Medicine

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