Title: Development and Validation of the UV Spectrophotometric Method of Ursodeoxycholic Acid in Methanol

Authors: Asha Devi, Abhishek soni, Dr Amit Chaudhary

 DOI: https://dx.doi.org/10.18535/jmscr/v7i10.149

Abstract

New developments have been taking place in the field of Development and validation of analytical method for the estimation of Ursodeoxychlic acid by using Uv spectroscopy. A simple, rapid, accurate and economical UV-spectroscopic method has been developed for the estimation of Ursodeoxycholic. The absorption maxima for Ursodeoxycholic acid is simulated liver fluid was found to be 232 nm. The drug follows linearity in the concentration ranges 1-10 µg/ml at 232nm with a correlation coefficient value of 0.998. The proposed method was applied to liver disease pharmaceutical formulation and % drug estimated was found to be in the range of 99.99% that is good agreement with the lable claim. The accuracy of the method was checked by recovery experiment performed at three levels i.e., 80%, 100%, 120%. The percent recovery was found to be in the range of 90-120%. The low values of % RSD are indicative of accuracy and reproducibility of method. The % RSD ˂ 2 indicates that method is precise.  

Keywords: UV- spectroscopy, Ursodeoxycholic acid, Method development, Accuracy, Precision.

References

  1. Fromn H. Gallstone dissolution and the cholesterol-bile acid-lipoprotien axis: propertious effect of Ursodeoxycholic acid. Gastroenterology 1984; 87: 229-233.
  2. Ward A, Brogden RN, Heel RC. Ursodeoxycholic acid: A review of its p’cological properties and therapeutic efficacy. Drug 1984; 27-95
  3. ICHQ, 2B, Validation of analytical procedure. Definition and terminology. CPMIII/5626/94. March 1995; Geneva, Switzerland.
  4. ICH, 2B, Validation of analytical procedure. Methodology (CPMP/95) Nov. 1996. Geneva, Switzerland
  5. Beuers U, Boyer JL, Paumgartner G. Ursodeoxycholic acid in cholestasis: potential mechanism of action and therapeutic application. Hepatology 1998; 28: 1449-53.
  6. Hagey LR, et al. Ursodeoxycholic acid in the Ursidae: biliary bile acids of bears, pandas, and related carnivores. J Lipid Res 1993; 34: 1911-19.
  7. Akare S, et al. Ursodeoxycholic acid modulates histone acetylation and induces differentitation and senescence. International Journal of Cancer. Journal International Du Cancer 119 (12): 2958-2969.
  8. Amaral JD, et al. Bile acids regulation of apoptosis by Ursodeoxycholic acid Journal of Lipid Research 2009; 50 (9): 1721-1734.
  9. Tait N, Little JM. The treatment of gall stone. BMJ 1995; 3(11): 99-105.
  10. Portincasa P, et al. Medical treatment of cholesterol gallstone: old, current and new perspectives. Curr Med chem. 2009; 16: 1531-1542.

Corresponding Author

Asha Devi

Abhilashi University, Mandi, Himachal Pardesh