Quality by Design Based RP-HPLC Method Development and Validation for the Simultaneous Estimation of Atazanavir and Ritonavir in Pure and Pharmaceutical Dosage Form
DOI:
https://doi.org/10.63682/jns.v14i11S.3087Keywords:
Simultaneous Estimation, Atazanavir, Ritonavir, Factorial Design, Quality by DesignAbstract
The method Development and validation for Simultaneous Estimation of Atazanavir and Ritonavir in pure and pharmaceutical dosage form is done by using RP-HPLC (Jasco-Series 2000) based on Quality by Design technique. Chromatographic separations were carried out on Analytical column: C18 column Waters X Bridge (4.6× 250mm id. particle size 5µm), UV detection: 247nm. Injection volume: 20 µL, Flow rate: 1.00 mL min -1, Temperature: Ambient, Run time: 10 min. 2 Level Factorial Design gave 4 runs at different pH and Mobile phase proportion. A mixture of acetonitrile, potassium dihydrogen phosphate (pH-3, KH2PO4) and methanol (90:10) was used as the mobile phase. The pH of the buffer solution was adjusted by phosphoric acid (H3PO4) and triethylamine (TEA). The wavelength of 247nm was used as detection at which both drugs gave good response.
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References
IUPAC. Compendium of Chemical Terminology, 2nd edition. (The Gold Book). PAC69, 1137, 1997. Glossary of terms used in computational drug design (IUPAC Recommendations.
Indian Pharmacopoeia, Indian Pharmacopoeial Commission, Controller of Publication, Government of India, Ministry of health and Family Welfare, Ghaziabad, India,( 2) 2010; 1657-1658.
Atazanavir + ritonavir (Addition) -- Adults". World Health Organization (WHO). Archived from the original on 3 February 2020. Retrieved 29 June 2017.
https://pubchem.ncbi.nlm.nih.gov/compound/16220172
https://www.drugbank.ca/drugs/DB08820
https://pubchem.ncbi.nlm.nih.gov/compound/16678941
https://www.drugbank.ca/drugs/DB09280
Nagaraju, Sreekanh, Chinna, Venugopal, Ravindranath, Bhanu, Sade. Reverse Phase HPLC method for determination of Ritonavir in pharmaceutical preparations. Int J Pharm Sci Review Res., 2012; 13(2);55-57.
Tiyyagura, Gunda, Chitturi, Sai, Abbaraju, Kodoori, Avinash. Method development and validation for the simultaneous estimation of Atazanavir and Ritonavir in pharmaceutical dosage form by RP-HPLC. Int J Pharm Chem Bio Sci., 2013; 3(1); 44-54.
Cattaneo D, Maggiolo F, RipamontiD , Perico N. J ChromatographicScience. 2008; 46(6); 485 – 489.
Dailly E, F Raffi, P Jolliet. Determination of atazanavir and other anti-retroviral drugs plasms levels by high performance liquid chromatography with uv- detection. Journal of chromatography B.2004. 813;353–358.
Anindita Behera. Der Pharmacia letter.2011;3(1);145-151.
Seshachalam U, Rao Narasimha D V L, Haribabu B and Chandrasekhar KB, Chromatographia, 2007; 65(5/6); 355-358.
Anupama, P., Viswanath, A., Sreenivasa babu, P., Sasidhar, R.; Development of novel and simple analytical method for the estimation of Atazanavir sulphate in pharmaceutical formulation by RP-HPLC; International Journal of Research in Pharmacy and Chemistry, (2013); 3: 645–648.
Dario, C., Franco, M., Diego, R., Norberto, P.; Determination of Atazanavir in human plasma by high-performance liquid chromatography with UV detection; Journal of Chromatographic Science, (2008); 46: 485–489.
Sreenivasa Rao, C., Yallappa Somappa, S., Badarinadh Gupta, P., Sreenivas, N., Hemant Kumar, S., Shankar Reddy, B., et al. .; Gradient RP-HPLC method for the determination of potential impurities in Atazanavir sulphate; Journal of Pharmaceutical and Biomedical Analysis, (2011); 55: 31–47.
Seshachalam, U., Narasimha Rao, D.V.L., Haribabu, B., Chandrasekhar, K.B.; Determination of Atazanavir in the presence of its degradation products by a stability-indicating LC method; Chromatographia, (2007); 65: 355–358.
Srinivasarao, K., Bibhuranjan, P., Raju, S.V.N., Padmaja Reddy, K., Ranga Reddy, V., Jaya Shree, A.; Development and validation of a simple, sensitive, selective and stability-indicating RP-UPLC method for the quantitative determination of ritonavir and its related compounds; Journal of Chromatographic Science, (2015); 53: 662–675.
Venugopal, N., Vijaya Bhaskar Reddy, A., Madhav, G.; Development and validation of a systematic UPLC-MS/MS method for simultaneous determination of three phenol impurities in Ritonavir; Journal of Pharmaceutical and Biomedical Analysis, (2014); 90: 127–133.
Manoj, G., Anil, B., Bhanubhai, S., Ishwarsinh, R., Urvish, D., Arpit, P., et al. .; Simultaneous determination of Ritonavir and Atazanavir in combined tablet dosage form by HPTLC; Asian Journal of Biomedical and Pharmaceutical Sciences, (2012); 2: 15–19.
Deshpande Padmanabh, B., Butle Santosh, R.; Stability indicating high performance thin layer chromatographic method for determination of Atazanavir and Ritonavir in combined tablet dosage forms; Journal of Pharmaceutical and Scientific Innovation, (2014); 3: 468–473.
Vasudha Pisal, B., Padmanabh Deshpande, B., Ashish, G., Sujith Nair, S.; High performance thin layer chromatographic determination of Atazanavir and Ritonavir in combined tablet dosage form; Der Chemica Sinica, (2013); 4: 21–25.
Sravan Kumar Reddy, G., Ashutosh Kumar, S., Raj Kumar, V.; An analytical method development and validation for simultaneous estimation of Atazanavir and Ritonavir in tablet dosage forms by using UPLC; Research Journal of Pharmaceutical, Biological and Chemical Sciences, (2014); 5: 1306–1314.
Sukhadev, P., Dnyaneshwar, D., Manjusha, S., Sanjay, S., Jyoti, M.; 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: 905–909.
Venkatesh, J., Chowdary, S., Anuroop Haritha, M., Prasad, D., Reddy, V.V.L.N., Anjani Prasad, V.; Reverse phase high performance liquid chromatographic estimation of Atazanavir and Ritonavir in pharmaceutical dosage form; Middle East Journal of Scientific Research, (2014); 19: 1076–1079.
Saritha, P., Girija Sastry, V., Vijaya Lakshmi, A., Veeraiah, E.; Stability-indicating liquid chromatographic method for the simultaneous determination of Atazanavir and Ritonavir in pharmaceutical formulation; International Journal of Pharmaceutical Sciences and Research, (2013); 4: 2659–2666.
Anindita, B., Kamini, S., Dannana Sankar, G., Swapan Moitra, K., Sudam Si, C.; Statistical correlation and simultaneous estimation of Atazanavir sulfate and Ritonavir in fixed dosage form by high performance liquid chromatography and high performance thin layer chromatography; Journal of Liquid Chromatography & Related Technologies, (2012); 35: 1731–1749.
Swetha Mallesh, A., Ravindra Reddy, Y.; Method development and validation of Atazanavir and Ritonavir in a combined dosage form by RP-HPLC method; International Journal of Pharmacy and Technology, (2011); 3: 3316–3334.
Nanda, R.K., Kulkarni, A.A., Yadav, P.B.; Simultaneous spectrophotometric estimation of Atazanavir sulfate and Ritonavir in tablets; Der Pharma Chemica, (2011); 3: 84–88.
Marina Antunes, V., Julia, P., Jorge Ribeiro, P., Eduardo, S., Rafael, L.; Ultra-performance liquid chromatographic method for simultaneous quantification of HIV non-nucleoside reverse transcriptase inhibitors and protease inhibitors in human plasma; Journal of the Brazilian Chemical Society, (2011); 22: 134–141.
Else, L., Watson, V., Tjia, J., Hughes, A., Siccardi, M., Khoo, S., et al. .; Validation of a rapid and sensitive high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) assay for the simultaneous determination of existing and new antiretroviral compounds; Journal of Chromatography B, Analytical Technologies in the Biomedical and Life Sciences, (2010); 878: 1455–1465.
ICH, “Validation of Analytical Procedures: Text and Methodology”, Q2 (R1) (2005) and ICH, “Stability Testing of New Drug Substances and Products”, Q1A (R2) (2005).
20 US FDA Guidance, “Analytical Procedures and Methods Validation” (2000).
Official methods of analysis, XVII, 15th ed. Association of Official Analytical Chemists International, Arlington, VA, (1990).
Validation of Compendial Methods <1225>, “The United States Pharmacopeia” (2012).
United States Pharmacopeial Convention, 36th ed. The United States Pharmacopoeia, Rockville, MD, (2012).
Guideline for Submitting Samples and Analytical Data for Methods Validation, US Food and Drug Administration (1987).
Dario Callaneo, Franco Maggiolo, Diego Ripamonti and Norberto Perico; Determination Of Atazanavir in Human Plasma by HPLC with UVDetection; Journal of Chromatographic Science 2008; 16;485-489.
Suneetha, S. Kathirvel and G.Ramachandrika. A validated Rp-Hplc method for simultaneous estimation of lopinavir and Ritonavir in combined dosage form. International Journal of Pharmacy and Pharmaceutical Sciences 2011; 3(1); 49- 51.
Behera, et al. Assay and stability study of Ritonavir bySpectrophotometric Method. Chronicles of Young Scientists 2011; 2(3); 161-167.
M. Padmalatha, K.Vanitha Prakash , Eranna Dopadally. Validated Reversed Phase High Performance Liquid Chromatography method for the estimation of Atazanavir Sulphate in Pharmaceutical formulations. Oriental Journal of Chemistry.2010; 26(1);123-127.
Jemal, Mohammed, Rao, Satish, Gatz, Michael, Whigan, Daisy. Analytical Technologies in the Biomedical and Life Sciences Journal of ChromatographyB. 2003;795(2);273-289.
Soyinka JO, Cyprian O, Omoruyi SI. Simultaneous liquid chromatographic analysis of ritonavir, quinine and 3 hydroxyquinine in human plasma, J Chromatogr B 2009;877:441–45.
Tulsidas Mishra, Pranav S. Shrivastav, Validation of Simultaneous Quantitative Method of HIV Protease Inhibitors Atazanavir, Darunavir and Ritonavir in Human Plasma by UPLC-MS/MS. The Scientific World J 2014; 2014, Article ID 482693 (12 pages).
Hsu A., Granneman G.R., Bertz R. J. Ritonavir: clinical pharmacokinetics and interactions with other anti-HIV agents. Clinical Pharmacokinetics 1998; 35 (4): 275-91.
Hung L.B.; Pacrcher, J.F.; Shores, J.C .; Ward,E.H. (2007).” Theoretical and experimental foundation for surface-coverage programming in gas-solid chromatography with an adsorbable carrier gas.
Lyold R.Synder and John W.Dolan (2008) A recent book provides a comprehensive treatment of the theory of high-performance gradient chromatography.
Tulsi Das Mishra, Hemal Kurani, Puran Singhal, Pranav S. Shrivastav. Simultaneous Quantitation of HIV-Protease Inhibitors Ritonavir, Lopinavir and Indinavir in Human Plasma by UPLC–ESI-MS-MS. J Chromatogr Sci 2012; Advance Access published May 4, 2012:1–11.
L.R.Synder, J.J.Kirkland, and J.W.Dolan,(2009) Introduction to Modern liquid Chromatography,
Josefin Koehn, Rodney J. Y. Ho. Novel Liquid Chromatography-Tandem Mass Spectrometry Method for Simultaneous Detection of Anti-HIV Drugs Lopinavir, Ritonavir, and Tenofovir in Plasma. Antimicrob Agents Chemother 2014; 58(5): 2675-80.
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