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Journal of Pharmaceutical Research

Article

Development and Validation of RP-HPLC Method for the Estimation of Dolutegravir and Rilpivirine in Bulk and its Tablet Dosage form
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Journal of Pharmaceutical Research

DOI: 10.18579/jopcr/v20i3.ms21040C

Year: 2021, Volume: 20, Issue: 3, Pages: 18-23

Original Article

Development and Validation of RP-HPLC Method for the Estimation of Dolutegravir and Rilpivirine in Bulk and its Tablet Dosage form

P Pravalika1,*, G Tulja Rani1, P Teja Sree1, Y Saritha1

1Malla Reddy Pharmacy College, Maisammaguda, Secunderabad, 500100, Telangana, India

*Corresponding Author Email: [email protected]

Creative Commons License

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

Abstract

An accurate and precise method was developed and validated for the simultaneous estimation of the Dolutegravir and Rilpivirine in Tablet dosage form. Chromatogram was run using Agilent C18 column (4.6x150mm, 5mm) with mobile phase containing KH2PO4 buffer of pH 3.5 and Acetonitrile in the ratio of 45:55 v/v was pumped through column at a flow rate of 1mL/min. Temperature was maintained at 30◦C. Selected wavelength was 240.0 nm. Retention time of Dolutegravir and Rilpivirine was found to be 2.239 min and 2.899 min respectively. %RSD of the Dolutegravir and Rilpivirine for system precision was found to be 0.9 and 0.6 respectively. Accuracy was performed in triplicate and the % Recovery was obtained as 99.33% and 100.5% for Dolutegravir and Rilpivirine respectively. LOD, LOQ values for Dolutegravir was 0.2 mg/mL, 0.6 mg/mL and for Rilpivirine was 0.02, 0.06 mg/mL respectively. So, the method developed was simple, accurate and reproducible can be adopted in regular Quality control test in pharmaceutical Industry.
Keywords: Dolutegravir; Rilpivirine; RPHPLC; Method development and Validation

References

  1. Min S, Sloan L, DeJesus E, Hawkins T, McCurdy L, Song I, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of dolutegravir as 10-day monotherapy in HIV-1-infected adults. AIDS. 2011;25(14):1737–1745. Available from: https://dx.doi.org/10.1097/qad.0b013e32834a1dd9
  2. Garvey L, Winston A. Rilpivirine: a novel non-nucleoside reverse transcriptase inhibitor. Expert Opinion on Investigational Drugs. 2009;18(7):1035–1041. Available from: https://dx.doi.org/10.1517/13543780903055056
  4. Girija BB, Balasaheb AK, Subhash TR, Jijabapu K, Sudhakar PS. Development and Validation of UV Spectrophotometric Method for Estimation of Dolutegravir Sodium in Tablet Dosage Form. Malaysian Journal of Analytical Sciences. 2015;19(6):1156–1163.
  6. Wang X, Penchala SD, Amara A, Else L, McClure M, Boffito M. A Validated Method for Quantification of Dolutegravir Using Ultra Performance Liquid Chromatography Coupled With UV Detection. Therapeutic Drug Monitoring. 2016;38(3):327–331. Available from: https://dx.doi.org/10.1097/ftd.0000000000000286
  7. Sk M, Gottumukkala A. Development and Validation of UV Spectrophotometric Methods for Estimation of Rilpivirine in Bulk and Pharmaceutical Formulation. International Journal of Pharmaceutical Sciences and Research. 2014;5(2):483–489.
  8. Cozzi V, Charbe N, Baldelli S, Castoldi S, Atzori C, Cattaneo D, et al. Development and Validation of a Chromatographic Ultraviolet Method for the Simultaneous Quantification of Dolutegravir and Rilpivirine in Human Plasma. Therapeutic Drug Monitoring. 2016;38(3):407–413. Available from: https://dx.doi.org/10.1097/ftd.0000000000000290
  9. Joseph J, Hepsebah NJR, Deepthi K. Analytical Method Development and Validation for the Simultaneous Estimation of Dolutegravir and Rilpivirine using RP-HPLC Method in Both Bulk and Pharmaceutical Dosage Form. European Journal of Biomedical and Pharmaceutical Sciences. 2016;3(07):237–243.
  10. Devi DV, Swarnalatha D, Subbareddy GV. Optimisation of RP-HPLC Method for Simultaneous Estimation of Dolutegravir and Rilpivirine in Binary Mixture by Using Design of Experiments. J. Global Trends Pharm Sci. 2019;10(2):6298–6310.

Copyright

© 2021 Published by Krupanidhi Educational Trust. This is an open access article under the CC BY license. (https://creativecommons.org/licenses/by/4.0/)

  • 25 November 2021

Year: 2021, Volume: 20, Issue: 3


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