Prasanthi, Dannana Gowri Sankar
Prasanthi1*, Dannana Gowri Sankar2
1Research Scholar, Department of Pharmaceutical Analysis and Quality Assurance, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.
2Department of Pharmaceutical Analysis and Quality Assurance, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.
Volume - 15,
Issue - 4,
Year - 2022
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Lopinavir and Ritonavir in its pure form as well as in tablet dosage form. Chromatography was carried out on a Kromasil C18 (4.6 x 250mm, 5µm) column using a mixture of TEA buffer (pH 4.0), Methanol in proportion 65:35 v/v as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 227nm. The retention time of the Lopinavir and Ritonavir were found to be 2.079, 4.045 min respectively. The method produce linear responses in the concentration range of 5-35µg/ml for both Lopinavir and Ritonavir. The method precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations. The optimized method was validated and proved to be suitable for the quality control of the mentioned drugs in their different pharmaceutical dosage forms, according to ICH guidelines. The developed method was found to be fairly precise, rapid and economical for simultaneous estimation of Lopinavir and Ritonavir when compared with the reported method.
Cite this article:
Prasanthi, Dannana Gowri Sankar. A Validated Stability Indicating RP-HPLC Method for Simultaneous Determination of Lopinavir and Ritonavir in Bulk and Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(4):1696-0. doi: 10.52711/0974-360X.2022.00284
Prasanthi, Dannana Gowri Sankar. A Validated Stability Indicating RP-HPLC Method for Simultaneous Determination of Lopinavir and Ritonavir in Bulk and Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(4):1696-0. doi: 10.52711/0974-360X.2022.00284 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-4-50
1. Skoog D A, West D M, Holler FJ: Introduction of analytical chemistry. Sounder college of publishing, Harcourt Brace college publishers. (1994), PP 1-5.
2. Sharma B K, Instrumental method of chemical analysis Meerut. (1999), PP 175-203.
3. Breaux J and Jones K: Understanding and implementing efficient analytical method development and validation. Journal of Pharmaceutical Technology (2003), 5, PP 110-114.
4. Willard, H. y. Merritt L.L, Dean J.A and Settle F.A “Instrumental methods of analysis” 7th edition CBS Publisher and Distributors, New Delhi, (1991), PP 436-439.
5. Meyer V.R. Practical High-Performance Liquid Chromatography, 4th Ed. England, John Wiley and Sons Ltd, (2004), PP 7-8.
6. Dias EM, Donato CL, Rossi, et al. LC method for studies on the stability of lopinavir and ritonavir in soft gelatin capsules, Chromatographia, 2006, 63(9-10): 437-443.
7. Suneetha A, Kathirvel S, Ramachandrika G, et al. A validated RP HPLC method for simultaneous estimation of lopinavir and ritonavir in combined dosage form, Int. J. of Pharmacy and Pharm. Sci., 2011, 3(1): 49-51.
8. Marzolini C, Telenti A, Buclin T, Biollaz J, Decosterd LA, et al. Simultaneous determination of the HIV protease inhibitors indinavir, amprenavir, saquinavir, ritonavir, nelfinavir and the non-nucleoside reverse transcriptase inhibitor efavirenz by high-performance liquid chromatography after solid-phase extraction, J. Chromatogr. B, 2000, 740(1): 43-58.
9. Damaramadugu R, Inamadugu J, Kanneti R, et al. Simultaneous Determination of Ritonavir and Lopinavir in Human Plasma after Protein Precipitation and LCMS-MS, Chromatographia, 2010,71(9/10): 815824.
10. D'Avolio A, Simiele M, Baietto L, et al. HPLC-MS method for the quantification of nine anti-HIV drugs from dry plasma spot on glass filter and their long-term stability in different conditions, J. of Pharm. and Biomed. Anal., 2010, 52(5): 774-780.
11. Myasein F, Kim E, Zhang J, et al. Rapid, simultaneous determination of lopinavir and ritonavir in human plasma by stacking protein precipitations and salting-out assisted liquid/liquid extraction, and ultrafast LC-MS/MS, Analytica Chimica Acta, 2009, 651(1): 112-116.
12. Yadav M, Rao R, Kurani H, et al. Application of a rapid and selective method for the simultaneous determination of protease inhibitors, lopinavir and ritonavir in human plasma by UPLC-ESI-MS/MS for bioequivalence study in Indian subjects, J. of Pharm. and Biomed. Anal., 2009, 49(4): 1115-1122.
13. International Conference on Harmonization Guidance for Industry, In: Q2A Text on Validation of Analytical Methods, Switzerland, IFPMIA, 1994, 1–4.
14. International Conference on Harmonization Guidance for Industry, In: Q2B Text on Validation of Analytical Methods, Switzerland, IFPMIA, 1996, 1–8.