Development and Validation of Stability Indicating LC-PDA Method for Simultaneous Assessment of Febuxostat and Ketorolac Tromethamine in Tablet Dosage Form

J.M. Derasari1; V.B. Patel3

doi:10.14233/ajchem.2017.20134

Issue

Vol. 29 No. 1 (2017): Vol 29 Issue 1

Issue Published : October 29, 2016

This work is licensed under a Creative Commons Attribution 4.0 International License.

Development and Validation of Stability Indicating LC-PDA Method for Simultaneous Assessment of Febuxostat and Ketorolac Tromethamine in Tablet Dosage Form

https://doi.org/10.14233/ajchem.2017.20134

J.M. Derasari1

1Pharmaceutical Quality Assurance, Gujarat Technological University, Chandkheda-382 028, India 2Parul Institute of Pharmacy and Research, Parul University, Vadodara-391 760, India 3Department of Pharmaceutical Quality Assurance, Babaria Institute of Pharmacy (Gujarat Technological University), Varnama-391 240, lndia *Corresponding author: Fax: +91 2668 262327; E-mail: jignashaderasari@gmail.com

V.B. Patel3

Asian Journal of Chemistry, Vol. 29 No. 1 (2017): Vol 29 Issue 1
Article Published : October 29, 2016

Abstract

A novel, rapid and highly selective stability indicating LC-PDA method was developed and validated for simultaneous assessment of febuxostat and ketorolac tromethamine in tablet dosage form. Agilent eclipus C18 (250 × 4.6 mm, 5 μm particle size) column and mobile phase-phosphate buffer (KH₂PO₄): acetonitrile (60:40 v/v, pH = 4 adjusted with orthophosphoric acid, 0.9 mL/min flow rate) were used for isocratic separation and eluent was monitored at 321 nm. Febuxostat and ketorolac tromethamine were retained at 7.933 and 3.797 min, respectively. The calibration plots were linear with correlation coefficients (r²) of 0.9980 and 0.9984 for febuxostat and ketorolac tromethamine, respectively. The proposed method was validated as per ICH Q2 (R1) guidelines. Stability study was conducted under various stressed conditions and obtained degradation products did not interfere with the detection of febuxostat and ketorolac tromethamine. Hence, the proposed method was sensitive, reproducible, stability indicating and was successfully applied to the routine quantitative-qualitative analysis.

Keywords

Febuxostat Ketorolac tromethamine Stability study Forced degradation Liquid chromatographic method.

Derasari1, J., & Patel3, V. (2016). Development and Validation of Stability Indicating LC-PDA Method for Simultaneous Assessment of Febuxostat and Ketorolac Tromethamine in Tablet Dosage Form. Asian Journal of Chemistry, 29(1), 69–75. https://doi.org/10.14233/ajchem.2017.20134

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References

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References

B.R.C. Sekhar Reddy and N.V.B. Rao, Carib. J. Sci. Technol., 1, 228 (2013).

H. Xie, Z. Wang, K. Deng, X. Jiang, L. Wang and G. Lv, J. Chromatogr. B: Analyt. Technol. Biomed. Life Sci., 970, 24 (2014).

M.H. Kadivar, P.K. Sinha, D. Kushwah, P. Jana, H. Sharma and A. Bapodra, J. Pharm. Biomed. Anal., 56, 749 (2011).

S. Orlandini, S. Fanali, S. Furlanetto, A.M. Marras and S. Pinzauti, J. Chromatogr. A, 1032, 253 (2004).

K.N. Rao, S. Ganapaty and A.L. Rao, Int. J. Res. Pharm. Chem., 2, 1104 (2012).

P. Bagga, M. Salman, H.H. Siddiqui, A.M. Ansari, T. Mehmood and K. Singh, Int. J. Pharm. Sci. Res., 2, 2655 (2011).

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Issue

Vol. 29 No. 1 (2017): Vol 29 Issue 1

Development and Validation of Stability Indicating LC-PDA Method for Simultaneous Assessment of Febuxostat and Ketorolac Tromethamine in Tablet Dosage Form

Abstract

Keywords

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