Article Sidebar

Download
PDF

Main Article Content

Abstract

The objective of this study was to develop and validate a method for simultaneous quantitative analysis of allopurinol and lesinurad in bulk drug and pharmaceutical formulations. An isocratic HPLC analysis method using a reverse phase Waters spherisorb ODS1 C18 column (250 mm × 4.6 mm, 5 μ) and a simple mobile phase without buffer was developed, optimized and fully validated. Analyses were carried out at a flow rate of 0.9 mL/min at 50 °C and monitored at 246 nm. This HPLC method exhibited good linearity, accuracy and selectivity. The recovery (accuracy) of both allopurinol and lesinurad from all matrices was greater than 98 %. The allopurinol and lesinurad peak detected in the samples of a forced degradation study and no interference of excepients or the degradation products formed during stress study. The method was rugged with good intra- and inter-day precision and sensitive. This stability indicating HPLC method was selective, accurate and precise for the simultaneous analysis of allopurinol and lesinurad in pharmaceutical formulations.

Keywords

Allopurinol Lesinurad HPLC analysis Method development Stress degradation.

Article Details

License

Copyright (c) 2020 Asian Journal of Organic & Medicinal Chemistry

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

How to Cite
Ramanjaneyulu, K., Venkata Ramana, K., & Prasada Rao, M. (2020). A New Validated Stability Indicating RP-HPLC Method for the Quantification of Allopurinol and Lesinurad in Bulk and Pharmaceutical Formulations. Asian Journal of Organic & Medicinal Chemistry, 5(1), 51–55. https://doi.org/10.14233/ajomc.2020.AJOMC-P244
Download Citation
Endnote/Zotero/Mendeley (RIS)
BibTeX

References

  1. J.H. Lewis and J.G. Stine, Nonsteroidal Antiinflammatory Drugs and Leukotriene Receptor Antagonists, In: Drug-Induced Liver Disease, Elsevier Inc., edn 3, Chap. 22, pp 369-401 (2013).
  2. P. Pacher, A. Nivorozhkin and C. Szabo, Therapeutic Effects of Xanthine Oxidase Inhibitors: Renaissance Half a Century after the Discovery of Allopurinol, Pharmacol. Rev., 58, 87 (2006); https://doi.org/10.1124/pr.58.1.6
  3. E.G. Russell and T.G. Cotter, New Insight into the Role of Reactive Oxygen Species (ROS) in Cellular Signal-Transduction Processes, Int. Rev. Cell Mol. Biol., 319, 221 (2015); https://doi.org/10.1016/bs.ircmb.2015.07.004
  4. H. Raber, A.N. Ali, A. Delthoff, K. Evoy, J. Helmen, L. Lim, D. Nguyen and E. Sheridan, ed: S.D. Ray, Anti-Inflammatory and Antipyretic Analgesics and Drugs Used in Gout, In: Side Effects of Drugs Annual, Chap. 8, pp. 77-85 (2016).
  5. R.M. Ted, Urate-Lowering Therapy, In: Kelley and Firestein’s Textbook of Rheumatology, edn 10, , Chap. 66, pp. 1061-1074 (2017).
  6. S.V. Narasayya, A. Maruthapillai, D. Sundaramurthy, J.A. Selvi and S. Mahapatra, Preparation, Pharmaceutical Properties and Stability of Lesinurad Co-Crystals and Solvate, Mater. Today Proc., 14, 532 (2019); https://doi.org/10.1016/j.matpr.2019.04.175
  7. G.W. Derek and P.S. Anthony, Hyperuricaemia and Gout, In: Medical Pharmacology and Therapeutics, edn 5, Chap. 31, pp. 385-389 ( 2018).
  8. D. Dastiagiriamma, C. Kistayya, N.M. Sowjanya and K. Hemalatha, Simultaneous Estimation of Lesinurad and Allopurinol by using Reverse Phase High Performance Liquid Chromatography in API and Marketed Formulation, Innov. Int. J. Med. Pharm. Sci., 3, 9 (2018).
  9. B. Rama Rao, R.R. Venkata and B.S. Venkateswarlu, Development and Validation of Reversed-Phase HPLC Isocratic Method for the Simultaneous Estimation of Lesinurad and Allopurinol, J. Pharma Res., 7, 257 (2018).
  10. M. Iqbal, E. Ezzeldin, R.N. Herqash and O. Alam, PLoS One, 14, e0213786 (2019); https://doi.org/10.1371/journal.pone.0213786
  11. W.S. Khayoon, M.Q. Al-Abaichy, M. Jasim and M.A. Al-Hamadany, Spectrophotometric Determination of Allopurinol in Tablet Formulation, J. Phys. Sci., 19, 23 (2008).
  12. S. Revathi, R.A. Gopi, N.K. Narendra and K.V. Kiran, Development and Validation of RP-HPLC Method for Simultaneous Estimation of Allopurinol and Alphalipoicacid in Bulk and Tablet Dosage Form, Int. J. Pharmacy Anal. Res., 5, 602 (2016).
  13. B. Rajkumar, T. Bhavya and A.A. Kumar, Reverse Phase HPLC Method Development and Validation for the Simultaneous Quantitative Estimation of a-Lipoic Acid and Allopurinol in Tablets, Int. J. Pharm. Pharm. Sci., 6, 307 (2014).
  14. K.A.M. Attia, N.M. El-Abasawi, A. El-Olemy and A.H. Abdelazim, Validated Stability Indicating High Performance Liquid Chromato-graphic Determination of Lesinurad, J. Chromatogr. Sci., 56, 358 (2018); https://doi.org/10.1093/chromsci/bmy010
  15. X.-Y. Zhou, L.-J. Yuan, Z. Chen, P.-F. Tang, X.-Y. Li, G.-X. Hu and J.-P. Cai, Determination of Lesinurad in Rat Plasma by a UHPLC-MS/MS Assay, Chem. Cent. J., 11, 121 (2017); https://doi.org/10.1186/s13065-017-0353-6