Volume : 09, Issue : 12, December – 2022

Title:

84.RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANIOUS ESTIMATION OF ATAZANAVIR AND COBICISTAT IN TABLET DOSAGE FORM

Authors :

M.Swathi, V.Kiran Kumar

Abstract :

A simple sensitive, and precise high performance liquid chromatographic method for the analysis of atazanavir and cobicistat has been developed and validated for the simultaneous determination of compounds in commercial pharmaceutical products. The compounds were well separated on ODS intersil C18 reverse phase column by the use of mobile phase of Orthophosphoric acid acetonitrile in a ratio of 45:55 v/v at a flow rate of 1.0 ml/min with detection wavelength at 272 nm. The retention time of atazanavir and cobicistat was found to be 4.135min and1.668min the method was validated in terms of linearity, precision, accuracy, and specificity, robustness, ruggedness and solution stability Degradation studies like acid, base, peroxide, thermal, uv and water. The method dies require only 10 min as run time for analysis which prove the adoptability of the method for the routine quality control analysis of the drug.
Keywords: Atazanavir and Cobicistat, RP‐HPLC, Simultaneous estimation.

Cite This Article:

Please cite this article in press M. Swathi et al, Formulation, RP-HPLC Method Development And Validation For Simultaneous Estimation Of Atazanavir And Cobicistat In Tablet Dosage Form., Indo Am. J. P. Sci, 2022; 09(12).

Number of Downloads : 10

References:

:

1. FDA Approved Drug Products: Reyataz (atazanavir) for oral use
2. FDA Approved Drug Products: Evotaz (atazanavir and cobicistat) oral tablets
3. Mathias AA, German P, Murray BP, Wei L, Jain A, West S, Warren D, Hui J, Kearney BP: Pharmacokinetics and pharmacodynamics of GS-9350: a novel pharmacokinetic enhancer without anti-HIV activity. Clin Pharmacol Ther. 2010 Mar;87(3):322-9. doi: 10.1038/clpt.2009.228. Epub 2009 Dec 30. [Article]
4. Nanda K, Stuart GS, Robinson J, Gray AL, Tepper NK, Gaffield ME: Drug interactions between hormonal contraceptives and antiretrovirals. AIDS. 2017 Apr 24;31(7):917-952. doi:
5. Sindu Priya, D., and Gowri Sankar, D., Stability-indicating reversed-phase high performance liquid chromatography method for the simultaneous estimation of darunavir and ritonavir. American Journal of Pharmatech Research, 2015. 6(1): 527-540.
6. Masthannamma, S.K., et al. Asian J Pharm Clin Res, 2016. 9(3): 62-70.
7. Panigrahy, U.P., Sunil Kumar A., A novel validated RP-HPLC-DAD method for the simultaneous estimation of Netupitant and Palonosetron in bulk and pharmaceutical dosage form with forced degradation studies Int J Pharm Sci, Rev. Res 2016. 36(2), 82-89.
8. Dnyaneshwar, S.P., et al. Development and validation of RP-HPLC method for the simultaneous estimation of atazanavir sulphate and ritonavir in bulk and formulations International Journal of Pharmacy and Pharmaceutical Sciences, 2013. 5(3): 33-38.
9. Purnima, V.B., et al. RP-HPLC method development for the assay and degradation study of cobicistat and atazanavir sulphate in bulk and combined dosage form. European Journal of Biomedical and Pharmaceutical sciences, 2016. 3(5): 450-461.
10.Pratik Vora, K., Ameta, S.C., Shirsat, M.K., Forced degration studies on atazanavir and cobicistat by RP-HPLC method, International Journal of Pharma and Bio Sciences, 2017. 8(1): 75-84.
10. Kumar, B.K., International Journal of Pharmacy and Industrial Research, 2015. 5 (4), 167-177
11. Nagaraju, P., et al. World Journal of Pharmacy and Pharmaceutical Sciences, 5(8): 650-671.
12. Venkata, S.S.N.M., Haribabu, B., and Rama Krishna Veni, P., Stability indicating RP-HPLC method for simultaneous estimation of atazanavir and cobicistat in tablets. British Journal of Pharmaceutical Research, 2016. 11(6): 1-10.
13. Pal, N., Rao, AS., and Ravikumar, P., Asian Journal of Chemistry, 2016. 28 (2): 273-276.