DISSOLUTION METHOD DEVELOPMENT WITH CHROMATOGRAPHIC METHOD FOR DETERMINATION OF DRUG RELEASE IN DISSOLUTION SAMPLES OF URSODEOXYCHOLIC ACID TABLETS.

Abstract

Ursodeoxycholic Acid is used in the treatment of Liver disease. An accurate and robust invitro method is developed and validated for measurement of drug release in Ursodeoxycholic Acid tablets. HPLC method for quantification of drug in dissolution samples of Ursodeoxycholic Acid tablet is developed and validated. Phosphate buffer (0.05M) of pH- 7.5 is used as dissolution medium and paddle (USP-II) as apparatus at 75 rpm. The sample was withdrawn after 60 minutes. The developed HPLC method was used for quantitative estimation of drug release in dissolution samples of Ursodeoxycholic Acid tablet. The HPLC column of Hypersil - C18, 250X4.6 mm, 5µm is used. The phosphate buffer of pH – 6.5 and acetonitrile was mixed in the ratio of 50:50v/v pumped at a flow rate of 1.0 ml/minute. The detection was made at wavelength of 210 nm. Through method validation, it is proved that the method is accurate, rugged, precise and robust. The method is linear over the concentration range of 50% – 150%. The method also found very precise. Mean recovery of Ursodeoxycholic Acid was found 99.6 ±38%. Keywords: Ursodeoxycholic Acid, Dissolution, chromatography, Method Validation.