Copyright (c) 2013 AJC
This work is licensed under a Creative Commons Attribution 4.0 International License.
Statistical Comparison of Two Liquid Chromatographic Methods for Ritonavir in Tablets
Corresponding Author(s) : Anindita Behera
Asian Journal of Chemistry,
Vol. 25 No. 11 (2013): Vol 25 Issue 11
Abstract
Two high performance liquid chromatography (HPLC) methods were developed for quantitation of ritonavir in raw material and tablet dosage form. The methods were validated and statistically compared. Both methods are carried out in a C18 column using the PDA detector at 240 nm. The first method, method A is carried out using methanol: acetonitrile: water in the ratio 87:10:3 (v/v/v) as mobile phase at a flow rate of 1 mL/min. The second method, method B is carried out using acetonitrile:methanol:buffer (pH = 6.2 ± 0.05) in the ratio 60:20:20 (v/v/v) as mobile phase at 1 mL/min. Both methods were validated according to ICH guidelines, showed good accuracy, precision, linearity and sensitivity. Two way anova and student's t-test was used to correlate the two methods and applied to raw materials and tablet dosage form. There was no significant difference between the two methods.
Keywords
Download Citation
Endnote/Zotero/Mendeley (RIS)BibTeX
- Indian Pharmacopoeia, Indian Pharmacopoeia Commission, Ghaziabad, India, Vol. 3, p. 1059 (2007).
- British Pharmacopoeia, The Stationary Office, London, Volume 1 and 2, p. 5227 (2009).
- United State Pharmacopoeia 30-NF25, United States Pharmacopoeal Convention. Inc., Twinbrook Parkway, Rockville, USA, p. 3143 (2007).
- R.S.Yekkala, D. Ashenafi, I. Marien, H. Xin, E. Haghedooren, J. Hoogmartens and E. Adams, J. Pharm. Biomed. Anal., 48, 1050 (2008).
- D.R. Weller, R.C. Brundage, H.H. Balfour Jr. and H.E. Vezina, J. Chromatogr. B, 848, 369 (2007).
- M.L. Turner, K.R. Walker, J.R. King and E.P. Acosta, J. Chromatogr. B, 784, 331 (2003).
- S. Frappier, D. Breilh, E. Diarte, B. Ba, D. Ducint, J.L. Pellegrin and M.C. Saux, J. Chromatogr. B, 714, 384 (1998).
- R. Heine, M. Davids, H. Rosing, E.C.M. Gorp, J.W. Mulder, Y.T. Heide, J.H. Beijnen and A.D. Huitema, J. Chromatogr. B, 877, 575 (2009).
- Y. Huang, M. Gandhi, R.M. Greenblatt, W. Gee, E.T. Lin and N. Messenkoff, Rapid. Comm. Mass Spectr., 22, 3401 (2008).
- Y.R. Hu, X.Y. Liu, Z.Z. Zhang and H.L. Qiao, Yaowu Fenxi Zazhi, 26, 1434 (2006).
- J. van der Lugt, J. Lange, A. Avihingsanon, J. Ananworanich, S. Sealoo, D. Burger, M. Gorowara, P. Phanuphak and K. Ruxrungtham, Antivir. Therap., 14, 1001 (2009).
- K. Chiranjeevi and K.P. Channabasavaraj, Int. J. Pharm. Sci. Res., 2, 596 (2011).
- I. Ponnilavarasan, A. Rajasekaran, J.G. Dharuman, D. Kalaiyarasi and M. Senthilkumar, Dig. J. Nanomater. Biostruc., 5, 771 (2010).
- Y. Usami, T. Oki, M. Nakai, M. Sagisaka and T. Kaneda, Chem. Pharm. Bull., 51, 715 (2003).
- A. Suneetha, S. Kathirvel and G. Ramachandrika, Int. J. Pharm. Pharm. Sci., 3, 49 (2011).
- T. Sudha, R. Vanitha and V. Ganesan, Der. Pharm. Chem., 3, 127 (2011).
- A.V. Sulebhavikar, U.D. Pawar, K.V. Mangoankar and N.D. Prabhunavelkar, E.-J. Chem., 5, 706 (2008).
- K.W. Garren, S. Rahim, K. Marsh and J.B. Morris, J. Pharm. Sci., 99, 626 (2010).
- R.N. Rao, B. Ramachandra, R.M. Vali and S.S. Raju, J. Pharm. Biomed. Anal., 53, 833 (2010).
- International Conference on Harmonization Specifications Q2A (R1): Validation of Analytical Procedures: Text and Methodology Test. November 5-10, Chicago. USA (2005).
- Y. Harumi, K. Hajime, N. Tetsuya and I. Aikichi, J. Chromatogr. B: Biomed. Sci. Appl., 755, 85 (2001).
- J. Ray, E. Pang and D. Carey, J. Chromatogr. B, 775, 225 (2001).
- J. Faux, N. Venisse, G. Le Moal, A. Dupuis and S. Bouquet, Chromatographia, 58, 421 (2003).
References
Indian Pharmacopoeia, Indian Pharmacopoeia Commission, Ghaziabad, India, Vol. 3, p. 1059 (2007).
British Pharmacopoeia, The Stationary Office, London, Volume 1 and 2, p. 5227 (2009).
United State Pharmacopoeia 30-NF25, United States Pharmacopoeal Convention. Inc., Twinbrook Parkway, Rockville, USA, p. 3143 (2007).
R.S.Yekkala, D. Ashenafi, I. Marien, H. Xin, E. Haghedooren, J. Hoogmartens and E. Adams, J. Pharm. Biomed. Anal., 48, 1050 (2008).
D.R. Weller, R.C. Brundage, H.H. Balfour Jr. and H.E. Vezina, J. Chromatogr. B, 848, 369 (2007).
M.L. Turner, K.R. Walker, J.R. King and E.P. Acosta, J. Chromatogr. B, 784, 331 (2003).
S. Frappier, D. Breilh, E. Diarte, B. Ba, D. Ducint, J.L. Pellegrin and M.C. Saux, J. Chromatogr. B, 714, 384 (1998).
R. Heine, M. Davids, H. Rosing, E.C.M. Gorp, J.W. Mulder, Y.T. Heide, J.H. Beijnen and A.D. Huitema, J. Chromatogr. B, 877, 575 (2009).
Y. Huang, M. Gandhi, R.M. Greenblatt, W. Gee, E.T. Lin and N. Messenkoff, Rapid. Comm. Mass Spectr., 22, 3401 (2008).
Y.R. Hu, X.Y. Liu, Z.Z. Zhang and H.L. Qiao, Yaowu Fenxi Zazhi, 26, 1434 (2006).
J. van der Lugt, J. Lange, A. Avihingsanon, J. Ananworanich, S. Sealoo, D. Burger, M. Gorowara, P. Phanuphak and K. Ruxrungtham, Antivir. Therap., 14, 1001 (2009).
K. Chiranjeevi and K.P. Channabasavaraj, Int. J. Pharm. Sci. Res., 2, 596 (2011).
I. Ponnilavarasan, A. Rajasekaran, J.G. Dharuman, D. Kalaiyarasi and M. Senthilkumar, Dig. J. Nanomater. Biostruc., 5, 771 (2010).
Y. Usami, T. Oki, M. Nakai, M. Sagisaka and T. Kaneda, Chem. Pharm. Bull., 51, 715 (2003).
A. Suneetha, S. Kathirvel and G. Ramachandrika, Int. J. Pharm. Pharm. Sci., 3, 49 (2011).
T. Sudha, R. Vanitha and V. Ganesan, Der. Pharm. Chem., 3, 127 (2011).
A.V. Sulebhavikar, U.D. Pawar, K.V. Mangoankar and N.D. Prabhunavelkar, E.-J. Chem., 5, 706 (2008).
K.W. Garren, S. Rahim, K. Marsh and J.B. Morris, J. Pharm. Sci., 99, 626 (2010).
R.N. Rao, B. Ramachandra, R.M. Vali and S.S. Raju, J. Pharm. Biomed. Anal., 53, 833 (2010).
International Conference on Harmonization Specifications Q2A (R1): Validation of Analytical Procedures: Text and Methodology Test. November 5-10, Chicago. USA (2005).
Y. Harumi, K. Hajime, N. Tetsuya and I. Aikichi, J. Chromatogr. B: Biomed. Sci. Appl., 755, 85 (2001).
J. Ray, E. Pang and D. Carey, J. Chromatogr. B, 775, 225 (2001).
J. Faux, N. Venisse, G. Le Moal, A. Dupuis and S. Bouquet, Chromatographia, 58, 421 (2003).