A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION RIBAVIRIN IN TABLETS
Keywords:
Nil, Ribavirin, Method development, Validation, EstimationAbstract
Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Ribavirin (200mg) in tablets.
Methods: The optimized method uses a reverse phase column, Enable Make KromasilC18 (250 X 4.6 mm; 5μ), a mobile phase of phosphate buffer (pH 4.2): acetonitrile in the proportion of 85:15 v/v, flow rate of 1.0 ml/min and a detection wavelength of 215 nm using a PDA detector.
Results: The developed method resulted in Ribavirin eluting at 2.606 min. Ribavirin exhibited linear in the range 25-150μg/ml. The precision is exemplified by the relative standard deviation of 0.4%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 0.24ng/ml and 0.73ng/ml respectively.
Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of Ribavirin in VIRAZIDE (200mg) tablets as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.
Â
Downloads
References
Sidwell RW, Bailey KW, Wong MH, Barnard DL, Smee DF. In vitro and in vivo influenza virus-inhibitory effects of viramidine. Antiviral Res 2005;68(1):10-7.
Ascio GS, Leble LH, Vaha BH, Chan KA. Ribavirin for patients with crimean congo hemorrhagic fever a systematic review and meta-Analysis. J Antimicrob Chemother 2011;66(6):1215–22.
Bausch DG, Hadi CM, Khan SH, Lertora JJ. Review of the literature and proposed guidelines for the use of oral Ribavirin as post exposure prophylaxis for lassa fever. Clin Infect Dis 2010;51(12):1435–41.
Soares W, Thomas S, Thomson G, Garner P. Ribavirin for crimean congo hemorrhagic fever systematic review and meta-analysis. BMC Infec Dis 2010;10(207):1471-2334.
Sylvie LR, Francoise SL, Agnes PL, Jean PZ, Germain BS, Souvignet CL. Ribavirin quantification in combination treatment of chronic hepatitis c. AAC 2003;47(1):124-9.
Hema CT, Ugolini G, Wachara PS, Sung KW, Shuan GS, Thamatas LJ. Human rabies neuropathy genesis diagnosis and management. Lancet Neurol 2013;12(5):498–13.
Alvarez D, Dieterich DT, Brau N, Moorehead L, Ball L, Sulkowski MS. Zidovudine, use but not weight-based ribavirin dosing impacts anemia during hcv treatment in HIV-infected persons. J Viral Hepat 2006;13(10):683-9.
Bani SF, Carrat F, Pol S, Hor R, Rosenthal E, Goujard C, et al. Risk factors for symptomatic mitochondrial toxicity in HIV/hepatitis C virus coinfected patients during interferon plus ribavirin based therapy. J Acquir Immune Defic Syndr 2005;40(1):47-52.
Margarita M, Osvaldo R, Beatriz Z. Hplc–ms/ms method for the intracellular determination of ribavirin monophosphate and ribavirin triphosphate in cemss cells. J Pharm Biomed Anal 2009;49(5):1233–40.
Wilson ZS, Hai ZB, Thomas A, Xiangyu J, Weng N. Development and validation of a liquid chromatography tandem mass spectrometry method for the determination of ribavirin in human plasma and serum. J Pharm Biomed Anal 2002:29(2);83-94
Lou AM, Lori PL. Bioanalysis of ribavirin in rat plasma by high pressure liquid chromatography tandem mass spectrometry. J Med Chem Scien 1972:15;1150.
Zhi-LZ, Xi YY, Huai YP, Tie FC, Qiu XL. Rapid and sensitive hplc-ms/ms method for pharmacokinetic assessment of ribavirin in healthy chinese. BMC 2008:22(12);1409-15.
Li TY, Mai NY, Chin CL. A sensitive and specific method for the determination of total ribavirin in human red blood cells by liquid chromatography tandem mass spectrometry. J Chromatogr Sci 2003;41(5):255-60.
Manel A, Darius M, Matthias C, Thomas M. Multiplex liquid chromatography-tandem mass spectrometry assay for simultaneous therapeutic drug monitoring of ribavirin, boceprevir, and telaprevir. AAC 2013;57(7):3147-58.
Antonio D, Allende I, Marco S, Daniel G. Validation of liquid liquid extraction method coupled with hplc-uv for measurement of ribavirin plasma levels in hcv-positive patients. J Chromatogr B 2006:835(2):127-30.
Avolio A, Nicolò A, Simiele M, Turini S, Agnesod D, Boglione L. Development and validation of a useful hplc-uv method for quantification of total and phosphorylated-ribavirin in blood and erythrocytes of hcv positive patients. J Pharm Biomed Anal 2012:66(10);376-80.
Suman A, Naveen K, Ramana M. Validated rp-hplc method for the estimation of ribavirin in formulation. lirpbs 2011:2(2);704-9.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures: Text and Methodology ICH Q2 (R1); 2005.