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Chromatographic Method Development and Validation for Quantitative Determination of Ursodeoxycholic Acid in Ursodeoxycholic Acid Tablets
Corresponding Author(s) : T.B. Sawant
Asian Journal of Chemistry,
Vol. 30 No. 10 (2018): Vol 30 Issue 10, 2018
Abstract
An HPLC assay method is developed for quantitative determination of ursodeoxycholic acid in ursodeoxycholic acid tablets. The developed method is a simple, accurate, rugged, precise and stability indicating chromatographic method. The stationary phase used in separation of known impurities and ursodeoxycholic acid drug was C18, 250 mm × 4.6 mm, 5 μm. The mobile phase was prepared by mixing of buffer and acetonitrile in the ratio of 50:50 v/v pumped at a flow rate of 1.5 mL/min. The developed chromatographic method is validated. The method is accurate, precise and linear over the concentration range of 50-150 %. Mean recovery of ursodeoxycholic acid tablets is found 99.7 ± 0.4. The method is simple and stability indicating, and hence can be used by common laboratories for the determination of ursodeoxycholic acid (assay) in ursodeoxycholic acid ER tablets.
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- G. Paumgartner and B. Ulrich, Hepatology, 36, 525 (2002); https://doi.org/10.1053/jhep.2002.36088.
- P. Angulo, Curr. Gastroenterol. Rep., 4, 37 (2002); https://doi.org/10.1007/s11894-002-0036-9.
- N. Anderson, D. Johnston and P. Vojvodic, J. Pharm. Biomed. Anal., 8, 987 (1990); https://doi.org/10.1016/0731-7085(90)80156-J.
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- A. Roda, C. Cerre, P. Simonini, C Vaccari and A Pistollo, J. Lipid Res., 33, 1393 (1992).
- M. Lu, China Pharmacy, 30, 033 (2008).
- S. Varinder, P. Kumar, S. Gurjeet, G. Shah and R. Dhawan, J. Pharm. Res., 9, 46 (2015).
- A. Peepliwal, C.G. Bonde and K.G. Bothara, J. Pharm. Biomed. Anal., 54, 845 (2011); https://doi.org/10.1016/j.jpba.2010.10.001.
- J. Mukherjee and T. Pal, Int. J. Pharm. Sci. Res., 2, 73 (2011); https://doi.org/10.13040/IJPSR.0975-8232.2(1).73-78.
- O. Boscolo, S. Flor, C. Dobercky, L. Salvo, V. Tripodi, S. Lucangioli. IOSR J. Pharm., 7, 111 (2017).
- M. Bakshi and S. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002); https://doi.org/10.1016/S0731-7085(02)00047-X.
- M. Blessy, R.D. Patel, P.N. Prajapati and Y.K. Agrawal, J. Pharm. Anal., 4, 159 (2014); https://doi.org/10.1016/j.jpha.2013.09.003.
- International Conference on Harmonization Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1) (2005).
- United States of Pharmacopoeia 38 NF−33, United States Pharmacopeial Convention General chapter <1225>, Validation of Compendial Procedures, pp. 1445-1450 (2015).
- United States of Pharmacopoeia 38 NF−33, United States Pharmacopeial Convention General Chapter <621>, Chromatography, pp. 424-434 (2015).
References
G. Paumgartner and B. Ulrich, Hepatology, 36, 525 (2002); https://doi.org/10.1053/jhep.2002.36088.
P. Angulo, Curr. Gastroenterol. Rep., 4, 37 (2002); https://doi.org/10.1007/s11894-002-0036-9.
N. Anderson, D. Johnston and P. Vojvodic, J. Pharm. Biomed. Anal., 8, 987 (1990); https://doi.org/10.1016/0731-7085(90)80156-J.
Anonymous, United States Pharmacopoeia 30−National Formulary 25 (USP 30−NF 25), United States Pharmacopoeial Convention Inc., Rockville, MD, USA, pp. 1787-1788 (2007).
Y. Alnouti, I. Csanaky and C. Klassen, J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 873, 209 (2008); https://doi.org/10.1016/j.jchromb.2008.08.018.
M. Scherer, C. Gnewuch, G. Schmitz and G. Liebisch, J. Chromatogr. B: Anal. Technol. Biomed. Life Sci.. 877, 3920 (2009); https://doi.org/10.1016/j.jchromb.2009.09.038.
X. Xiang, Y. Han, M. Neuvonen and M. Niemi, J. Chromatogr. B: Anal. Technol. Biomed. Life Sci.. 878, 51 (2010). https://doi.org/10.1016/j.jchromb.2009.11.019.
A. Roda, C. Cerre, P. Simonini, C Vaccari and A Pistollo, J. Lipid Res., 33, 1393 (1992).
M. Lu, China Pharmacy, 30, 033 (2008).
S. Varinder, P. Kumar, S. Gurjeet, G. Shah and R. Dhawan, J. Pharm. Res., 9, 46 (2015).
A. Peepliwal, C.G. Bonde and K.G. Bothara, J. Pharm. Biomed. Anal., 54, 845 (2011); https://doi.org/10.1016/j.jpba.2010.10.001.
J. Mukherjee and T. Pal, Int. J. Pharm. Sci. Res., 2, 73 (2011); https://doi.org/10.13040/IJPSR.0975-8232.2(1).73-78.
O. Boscolo, S. Flor, C. Dobercky, L. Salvo, V. Tripodi, S. Lucangioli. IOSR J. Pharm., 7, 111 (2017).
M. Bakshi and S. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002); https://doi.org/10.1016/S0731-7085(02)00047-X.
M. Blessy, R.D. Patel, P.N. Prajapati and Y.K. Agrawal, J. Pharm. Anal., 4, 159 (2014); https://doi.org/10.1016/j.jpha.2013.09.003.
International Conference on Harmonization Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1) (2005).
United States of Pharmacopoeia 38 NF−33, United States Pharmacopeial Convention General chapter <1225>, Validation of Compendial Procedures, pp. 1445-1450 (2015).
United States of Pharmacopoeia 38 NF−33, United States Pharmacopeial Convention General Chapter <621>, Chromatography, pp. 424-434 (2015).