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

  • Tukaram B Sawant Chhatrapati Shivaji College, Omerga, Maharashtra, India. Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, 431004, MS, India
  • Dhananjay V Mane Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, 431004, MS, India
DOI https://doi.org/10.22270/jddt.v8i1.1547

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 The sample was withdrawn after 60 minutes.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.

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Author Biographies

Tukaram B Sawant, Chhatrapati Shivaji College, Omerga, Maharashtra, India. Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, 431004, MS, India

Chhatrapati Shivaji College, Omerga, Maharashtra, India.Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, 431004, MS, India

Dhananjay V Mane, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, 431004, MS, India

Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, 431004, MS, India

References

1. Bouchier IAD: The medical treatment of gallstones. Annu Res Med 1980; 31:59-77.
2. Dowling RH: Cholelithiasis: medical treatment. Clin Gastroenterol 1983; 12:125-178.
3. Bergmann K, Epple-Gutsfeld M, Leiss O: Differences in the effects of chenodeoxycholic acid and ursodeoxycholic acid on biliary lipid secretion and bile acid synthesis in patients with gallstones. Gastroenterology: 1984; 87: 136-143.
4. Leuschner U, Leuschner M, Hubner K: Gallstone dissolution with patients with chronic active hepatitis. Gastroenterology: 1981; 80: 1208-1209.
5. Mukharjee J, Pal TK, Development and Validation of RP_HPLC method to determine Ursodeoxycholic Acid in Pharmaceutical Dosage Forms; IJPSR, 20111; 2(1):73-78.
6. Peepliwal A, Bonde CG, Bothara KG. "A validated RP-HPLC method for quantitative determination of related impurities of ursodeoxycholic acid (API) by refractive index detection." Journal of pharmaceutical and biomedical analysis 2011; 54(4): 845-849.
7. Shen, Zhaojun, et al. "A Validated RP-HPLC Method for Quantitative Determination of Related Impurities of Cholic Acid Bulk Drugs." Acta Chromatographica 2017; 1-5.
8. Won Park Je, Nguyen Huu Hoang, and Nguyen Lan Huong. "Analysis of Ursodeoxycholic Acid Using Ultra-Performance Liquid Chromatography with Tandem Mass Spectrometry." Current Pharmaceutical Analysis 2016; 12(3):185-191.
9. Hasan N, et al. "Development and Validation of RP-LC-UV Method for Determination of Ursodeoxycholic Acid in Capsule and Human Serum." World Applied Sciences Journal, 2014; 32(4):560-566.
10. International Conference on Harmonization Harmonized Tripartite Guideline. (2005) Validation of Analytical procedures: Q2(R1).
11. United States of Pharmacopoeia 38 NF 33 (2015). United States Pharmacopeial Convention General chapter <1225>, Validation of Compendial Procedures, pp. 1445-1450.
12. United States of Pharmacopoeia 38 NF 33 (2015), United States Pharmacopeial Convention General chapter <621>, Chromatography, pp. 424-434.
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How to Cite
1.
Sawant T, Mane D. DISSOLUTION METHOD DEVELOPMENT WITH CHROMATOGRAPHIC METHOD FOR DETERMINATION OF DRUG RELEASE IN DISSOLUTION SAMPLES OF URSODEOXYCHOLIC ACID TABLETS. JDDT [Internet]. 14Jan.2018 [cited 18May2024];8(1):23-8. Available from: https://jddtonline.info/index.php/jddt/article/view/1547
Issue
Vol 8 No 1 (2018): VOLUME 8, ISSUE 1, Jan-Feb 2018
Section
Research

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