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Development and Validation of Piribedil in Tablet Dosage Form by HPLC: A QbD and OFAT Approach
Corresponding Author(s) : T.S.S. Jagan Mohan
Asian Journal of Chemistry,
Vol. 29 No. 5 (2017): Vol 29 Issue 5
Abstract
Piribedil is considered as an antiparkinson agent or dopamine agonist type of medication. A simple, selective, rapid, precise, accurate and economical reverse phase stability indicating HPLC method has been developed and validated as per ICH guidelines for estimation of piribedil (PI) in sustained release tablet dosage form. Xterra RP18 (150 × 4.6 mm, 5 μ) stationary phase by using an isocratic mobile phase consists of pH 2.5 phosphate buffer of 0.05 M and acetonitrile in the ratio of (80:20 v/v) at a flow rate of 1.5 mL/min and column temperature of 50 °C. Piribedil was detected at 240 nm. The chromatographic procedure separated piribedil and its potential degradation products in an overall analysis time of 6 min with piribedil eluting at about 3 min. Piribedil tablets were exposed to thermal, photolytic, acid, base and oxidative stress conditions. The degradation products are well resolved from the piribedil peak indicating the stability indicating the significance of the method. The assay method was found to be linear in the concentration range of 0.024-75 μg/mL with a correlation coefficient of 0.9999. The percentage recovery of assay was found between 100.4 and 100.6. Considerable degradation was found to occur in base hydrolysis, water hydrolysis and oxidation. In the present study a 13.2 % forced degraded sample is used in the robustness parameter for both QbD and OFAT approaches which can produce a robust HPLC method. The proposed method can be used for routine analysis in quality control laboratories for its formulated product.
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- https://www.en.wikipedia.org/wiki/Piribedil (accessed on 30.11.16).
- https://www.1mg.com/generics/piribedil-210524.
- G. Altiokka, N. Can and H. Aboul-Enein, Chromatographia, 67, 905 (2008); https://doi.org/10.1365/s10337-008-0626-2.
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- K.E. Monks, H.-J. Rieger and I. Molnár, J. Pharm. Biomed. Anal., 56, 874 (2011); https://doi.org/10.1016/j.jpba.2011.04.015.
- M. McBrien, Chromatogr. Today, 3, 30 (2010).
- ICH, Pharmaceutical Development, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, August 2009.
- G. Szepesi, M. Gazdag and K. Mihályfi, J. Chromatogr. A, 464, 265 (1991); https://doi.org/10.1016/S0021-9673(00)94245-6.
- G.P. Carr and J.C. Wahlich, J. Pharm. Biomed. Anal., 8, 613 (1990); https://doi.org/10.1016/0731-7085(90)80090-C.
- D.R. Jenke, J. Liq. Chromatogr., 19, 737 (1996); https://doi.org/10.1080/10826079608005534.
- P.G. Alden, W. Potts, D. Yurach, Waters Application Note 70003719EN, (2010).
- ICH, Stability Testing: Photostability Testing of New Active Substances and Medicinal Products, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, November (1996).
- ICH, Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, November (2005).
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References
https://www.en.wikipedia.org/wiki/Piribedil (accessed on 30.11.16).
https://www.1mg.com/generics/piribedil-210524.
G. Altiokka, N. Can and H. Aboul-Enein, Chromatographia, 67, 905 (2008); https://doi.org/10.1365/s10337-008-0626-2.
S. Sarati, G. Guiso, R. Spinelli and S. Caccia, J. Chromatogr. B Biomed. Sci. Appl., 563, 323 (1991); https://doi.org/10.1016/0378-4347(91)80038-E.
K.B.V. Rohith, G.V. Ramana, N.M. Latha, P. Supriya and U. Harini, Asian J. Pharm. Clin. Res., 9, 342 (2016).
K.E. Monks, H.-J. Rieger and I. Molnár, J. Pharm. Biomed. Anal., 56, 874 (2011); https://doi.org/10.1016/j.jpba.2011.04.015.
M. McBrien, Chromatogr. Today, 3, 30 (2010).
ICH, Pharmaceutical Development, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, August 2009.
G. Szepesi, M. Gazdag and K. Mihályfi, J. Chromatogr. A, 464, 265 (1991); https://doi.org/10.1016/S0021-9673(00)94245-6.
G.P. Carr and J.C. Wahlich, J. Pharm. Biomed. Anal., 8, 613 (1990); https://doi.org/10.1016/0731-7085(90)80090-C.
D.R. Jenke, J. Liq. Chromatogr., 19, 737 (1996); https://doi.org/10.1080/10826079608005534.
P.G. Alden, W. Potts, D. Yurach, Waters Application Note 70003719EN, (2010).
ICH, Stability Testing: Photostability Testing of New Active Substances and Medicinal Products, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, November (1996).
ICH, Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, November (2005).
www.waters.com/webassets/cms/librar y/docs/720004072en.pdf (accessed on 30.11.16).
R. Peraman, K. Bhadraya and Y.P. Reddy, Int. J. Anal. Chem., Article ID 868727 (2015); https://doi.org/10.1155/2015/868727.