Validated stability indicating RP-HPLC method for the determination of dolutegravir and rilpivirine in bulk and pharmaceutical dosage forms
Article Sidebar
-
Development, Dolutegravir, Rilpivirine, RP-HPLC, Validation
Abstract
For simultaneous analysis of Dolutegravir and Rilpivirine utilizing RP-HPLC, an accurate, rapid, economical, quick and reliable assay technique was developed and tested. Successful chromatographic detachment using acetonitrile and 0.1 percent tri ethyl amine in the water of pH-2.5 adjusted with 0.1% orthophosphoric acid in 40:60 v/v as a movable phase with a flow of 1 ml/min and UV observation at 230 nm. Chromatography at ambient temperature was performed isocratically, and the run time was 10 min. By injecting the norm six times, device suitability parameters were studied and the findings were far below the acceptance criteria. The linearity analysis was performed at levels ranging from 10% to 150% and the R2 value was found to be 0.999. Precision has been found to be 0.8 for repeatability and 1.2 for intermediate precision. Assay of the commercialized formulation was performed by using the above method, and we get 100.01 percent was present. For routine analysis in drug testing, this chromatographic approach can be effectively implemented. By using the above technique, an assay of the marketed formulation was performed and found to be within the limit. Degradation studies were carried out on Dolutegravir and Rilpivirine, with a purity threshold greater than purity angle in all conditions and within the acceptable range. The above-mentioned technique was validated according to ICH guidelines.
Full text article
References
Balasaheb, B. G., Balasaheb, A. K., Subhash, T. R., Jijabapu, K., Sudhakar, P. S. 2015. Development and validation of UV spectrophotometric method for estimation of dolutegravir sodium in tablet dosage form. Malaysian Journal of Analytical Sciences, 19(6):1156–1163.
Ballard, O., Morrow, A. L. 2013. Human milk composition: nutrients and bioactive factors. Pediatric Clinics, 60(1):49–74.
Beck, G., Habicht, G. S. 1996. Immunity and the Invertebrates. Scientific American, 275(5):60–66.
BNF 2015. British national formulary: 69th edition. In The authority on the selection and use of medicines, pages 1–1197. British medical association. ISBN: 9780857111562.
ClinicalTrials.gov 2012. TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination with Tenofovir + Emtricitabine. U. S. National Library of Medicine. Updated on: 29 March 2016.
ClinicalTrials.gov 2012. TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Com- bination with 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors. U. S. National Library of Medicine. Updated on: 1 April 2016.
Cozzi, V., Charbe, N., Baldelli, S., Castoldi, S., Atzori, C., Cattaneo, D., Clementi, E. 2016. Development and Validation of a Chromatographic Ultra- violet Method for the Simultaneous Quantification of Dolutegravir and Rilpivirine in Human Plasma. Therapeutic Drug Monitoring, 38(3):407–413.
Damel, M. C., Prdeshi, A. N. 2017. Stability indicating HPLC method for rilpivirine and dolutegravir sodium. Eur J Biomed Pharm Sci, 4:454–459.
De Clercq, E. 1998. The role of non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the therapy of HIV-1 infection. Antiviral Research, 38(3):153–179.
Diabetes Care 2013. Diagnosis and Classification of Diabetes Mellitus. American Diabetes Association, 37(Supple 1):81–90.
Dolutegravir 1975. Dolutegravir sodium monograph for professionals. Drugs.com. Updated on: 5 October 2020.
Europea, X. U. 2004. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union. L, 136:34–57.
Goebel, F., Yakovlev, A., Pozniak, A. L., Vinogradova, E., Boogaerts, G., Hoetelmans, R., de Béthune, M.-P. P., Peeters, M., Woodfall, B. 2006. Short-term antiviral activity of TMC278–a novel NNRTI –in treatment-naive HIV-1-infected subjects. AIDS, 20(13):1721–1726.
Guideline for good clinical practice 1996. International conference on harmonization of technical requirements for registration of pharmaceutics for human use. pages 1–57. ICH Harmonised Tripartite Guideline.
Johnson & Johnson 2002. Johnson & Johnson Acquires Tibotec-Virco. Timeline of Our Story.
Joseph, J., Hepsebah, N. J. R., Deepthi, K. 2016. Analytical method development and validation for the simultaneous estimation of Dolutegravir and Rilpivirine using the RP-HPLC method in both bulk and pharmaceutical dosage forms. European j. biomed. pharm, 3(5):237–243.
Kay, A. B. 2000. Overview of ’Allergy and allergic diseases: with a view to the future’. British Medical Bulletin, 56(4):843–864.
Kirch, W. 2008. Encyclopedia of Public Health. First edition. In Volume 1: A - H Volume 2: I - Z, pages 676–677. Springer. ISBN: 978-1-4020-5614-7.
Krämer, A., Kretzschmar, M., Krickeberg, K. 2010. Modern infectious disease epidemiology: Concepts, methods, mathematical models, and public health. In First edition. Springer Science and Business Media, page 443. ISBN: 978-0-387-93835-6.
Masuda, T. 2011. Non-enzymatic functions of retroviral integrase: the next target for novel anti-HIV drug development. Frontiers in Microbiology, 2:210.
McNaught, A. D., Wilkinson, A. 1997. Compendium of chemical terminology. In IUPAC. The Gold Book, Second Edition. ISBN: 0865426848.
Moore, R. D., Chaisson, R. E. 1999. Natural history of HIV infection in the era of combination antiretroviral therapy. AIDS, 13(14):1933–1942.
NIH 2016. Liver Diseases. MedlinePlus. National Institutes of Health, U. S. National Library of Medicine. Updated on: 8 July 2021.
Pozniak, A., Morales-Ramirez, J., et al. 2007. 48-week primary analysis of trial TMC 278-C204, TMC 278 demonstrates potent and sustained efficacy in ART-naïve patients. 14th Conference on Retroviruses and Opportunistic Infections. Abstract: J- 1010, Paper: 144LB.
Pregnancy 2013. Pregnancy, condition information. Eunice kennedy shriver national institute of child health and human development. Updated on: 18 December 2020.
Roberts, R. J. 2002. Fish pathology, Third Edition. Journal of fish diseases, 25(2):125.
Satyadev, T. N. V. S. S., Bhargavi, C. H. 2018. Development and validation of high performance liquid chromatographic method for the determination of dolutegravir in human plasma. Der pharmacia sinica, 6(4):65–72.
Sepkowitz, K. A. 2001. AIDS — The First 20 Years. New England Journal of Medicine, 344(23):1764–1772.
Stellbrink, H. J. 2007. Antiviral drugs in the treatment of AIDS: what is in the pipeline? European Journal of Medical Research, 12(9):483–495.
WHO 2013. Diarrhoeal disease Fact sheet N 330. World Health Organization.
Authors
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.