• P-ISSN 0973-7200 E-ISSN 2454-8405
  • Follow us

Journal of Pharmaceutical Research

Article

Journal of Pharmaceutical Research

Year: 2023, Volume: 22, Issue: 3, Pages: 172-177

Original Article

Development and Validation of new RP-HPLC Method for the Simultaneous Estimation of Elbasvir and Grazoprevir in Combined Pharmaceutical Dosage Form

Abstract

A reliable and exact technique was formulated for concurrently determining Elbasvir and Grazoprevir in tablet dosage forms. Chromatogram was developed by running a sample through Zodiac C18 column (4.6 x 150 mm, 5 µm) with the mobile phase containing Orthophosphoric acid (0.1%) and Acetonitrile in the ratio 50:50 v/v. The solution was pumped through the column at a flow rate of 1 ml/min, while maintaining the column temperature at 30°C. The optimized wavelength selected was 260 nm. The retention times for Elbasvir and Grazoprevir were determined to be 2.32 min and 3.30 min, respectively. The percentage recovery was found to be 100.16% for Elbasvir and 99.49% for Grazoprevir. The LOD and LOQ values obtained from the regression equations for Elbasvir were 0.30 mg/ml and 0.92 mg/ml, and for Grazoprevir were 0.28 mg/ml and 0.86 mg/ml, respectively. The regression equation for Elbasvir was found to be y = 2282.5x + 2407.2, and for Grazoprevir, it was y = 2366.5x + 7740.4. In conclusion, the developed method proved to be simple and economical, demonstrating successful application for the simultaneous estimation of both Elbasvir and Grazoprevir in bulk and combined tablet formulations.

Keywords: Elbasvir, Grazoprevir, RP­HPLC, Validation, Simultaneous estimation

References

  1. Al-Salama ZT, Deeks ED. Elbasvir/Grazoprevir: A Review in Chronic HCV Genotypes 1 and 4. Drugs. 2017;1(4):911–921. Available from: https://pubmed.ncbi.nlm.nih.gov/28417245/
  2. Kassas ME, Elbaz T, Latif YAE, Esmat G. Elbasvir and grazoprevir for chronic hepatitis C genotypes 1 and 4. Expert Review of Clinical Pharmacology. 2016;9(11):1413–1421. Available from: https://scholar.cu.edu.eg/sites/default/files/tamerbaz/files/elbasvir.pdf
  3. Feng H, Caro L, Fandozzi CM, Guo Z, Talaty J, Wolford D, et al. Pharmacokinetic Interactions Between Elbasvir/Grazoprevir and Immunosuppressant Drugs in Healthy Volunteers. The Journal of Clinical Pharmacology. 2018;58(5):666–673. Available from: https://doi.org/10.1002/jcph.1052
  4. Karaoui LR, Mansour H, Chahine EB. Elbasvir-grazoprevir: A new direct-acting antiviral combination for hepatitis C. American Journal of Health System and Pharmacology. 2017;74:1533–1573. Available from: https://doi.org/10.2146/ajhp160558
  5. Liu H, HX, Song W, Zhang Y, Yu S, Huang X. Validated UPLC/MS/MS assay for quantitative bioanalysis of elbasvir in rat plasma and application to pharmacokinetic study. Journal of chromatography-B, Analytical technologies in the biomedical and life sciences. 2016;1015:150–156. Available from: https://doi.org/10.1016/j.jchromb.2016.02.025
  6. Haritha P, Battula SR, Yeturu S. Picogram level quantification of grazoprevir and elbasvir with deuterated internal standards in human plasma samples by LC-ESI-MS/MS. Indian Journal of Pharmaceutical Education and Research. 2016;50:612–618. Available from: https://doi.org/10.5530/ijper.50.4.14
  7. Attia KAM, El-Abasawi NM, El-Abasawi A, Abdelazim AH. Simultaneous spectrophotometric determination of elbasvir and grazoprevir in a pharmaceutical preparation. Journal of AOAC International Drug Formulations and Clinical Methods. 2018;101:394–398. Available from: https://doi.org/10.5740/jaoacint.17-0037
  8. Gopal NM, Sridhar C, . Stability indicating validated RP-UPLC method for simultaneous determination of elbasvir and grazoprevir in bulk and pharmaceutical dosage form. International Journal of Pharmaceutical Sciences Review and Research. 2017;44:43–48. Available from: https://globalresearchonline.net/journalcontents/v44-2/09.pdf
  9. Sumalatha N, Reddy N, Vishal V, Kumar B. Analytical Method Development and Validation of Elbasvir and Grazoprevir in Bulk and Tablet Formulations by RP- HPLC. International Journal of Pharmaceutical Science Invention. 2017;6:1–5. Available from: https://www.ijpsi.org/Papers/Vol6(8)/A06080105.pdf
  10. Khalid A, Nasr M, El-Abasawi A, El-Olemy, Ahmed H, Abdelazim M, et al. Simultaneous Determination of Elbasvir and Grazoprevir in Their Pharmaceutical Preparation using High-Performance Liquid Chromatographic Method. Journal of chromatographic science. 2018;56:1–7. Available from: https://doi.org/10.1093/chromsci/bmy049
  11. Noorulla KM, Fathima N, . Analytical method development and validation for simultaneous estimation of elbasvir and grazoprevir in tablet dosage forms by RP-HPLC. International Journal of Innovative Pharmaceutical Science and Research. 2017;5:89–103. Available from: https://doi.org/10.21276/IJIPSR.2017.05.08.571
  12. Manoja B, Abhishiktha V, Latha M, Satyavati B, Lalitha D, T. Development and validation of a RP-HPLC method for simultaneous determination of elbasvir and grazoprevir in pure and pharmaceutical dosage form. Journal of Scientific Research in Pharmacy. 2018;7:92–95. Available from: https://zenodo.org/records/1326526

Copyright

© 2023 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/

DON'T MISS OUT!

Subscribe now for latest articles and news.