Development and Validation of a Stability-Indicating Method for the Estimation of Ursodeoxycholic Acid using the RP-HPLC method

Authors

  • Suraj J. Patil  Department of Chemistry, Rajarambapu College of Pharmacy Kasegaon, Dist-Sangli, India
  • Sandeep R. Kane  Department of Chemistry, Rajarambapu College of Pharmacy Kasegaon, Dist-Sangli, India
  • Shrinivas K. Mohite  Department of Chemistry, Rajarambapu College of Pharmacy Kasegaon, Dist-Sangli, India
  • Chandrakant S. Magdum  Department of Chemistry, Rajarambapu College of Pharmacy Kasegaon, Dist-Sangli, India

Keywords:

RP-HPLC, Stability indicating, Ursodeoxycholic acid, Validation

Abstract

Given that currently published analytical methods of ursodeoxycholic acid (UDCA) involve complex procedures and equipment, the purpose of this paper was to present the validation of a simple, rapid, accurate and precise isocratic UV and stability indicating RP-HPLC method for quantification residual solvents of ursodeoxycholic acid. Such a method would be critical in prospective developers. Validated method demonstrated Ursodeoxycholic acid separation without interference from the solvents with the most relevance for developing of tablet pharmaceutical drug carries. Method was linear over studied Ursodeoxycholic acid concentration range (2-10 µg/mL) with acceptable precision and accuracy. Method validation is carried out by using linearity (regression coefficient =0.934), accuracy (96.08 to 98.25), precision (intraday= % R.S.D. – 0.98and interday = % R.S.D. - 1.52), LOD (0.1) and LOQ (0.303), robustness (change in flow rate, change in wavelength and mobile phase composition was found to be 3.383 ± 3.47 respectively). Development and validation of Ursodeoxycholic acid was successfully carried out by using UV and HPLC method.

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International Journal of Scientific Research in Chemistry

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Published

2020-10-30

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Volume 5, Issue 5, September-October-2020

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Research Articles

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[1]
Suraj J. Patil, Sandeep R. Kane, Shrinivas K. Mohite, Chandrakant S. Magdum, " Development and Validation of a Stability-Indicating Method for the Estimation of Ursodeoxycholic Acid using the RP-HPLC method, International Journal of Scientific Research in Chemistry(IJSRCH), ISSN : 2456-8457, Volume 5, Issue 5, pp.32-45, September-October-2020.