Development and validation of a stability-indicating HPLC method for analysis of celecoxib (CXB) in bulk drug and microemulsion formulations

• Autorzy: Baboota, S. , Faiyaz, S. , Ahuja, A. , Ali, J. , Shafiq, S. , Ahmad, S.
• Języki publikacji: EN

Abstrakty

EN

A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for analysis of celecoxib (CXB), a selective COX-2 inhibitor, both in bulk drug and in microemulsions. Reversed-phase chromatography was performed on a C18 column with methanol–water, 75:25 (%, v/v), as mobile phase at a flow rate of 1.25 mL min-1. Detection was performed at 250 nm and a sharp peak was obtained for CXB at a retention time of 4.8 ± 0.01 min. Linear regression analysis data for the calibration plot showed there was a good linear relationship between response and concentration in the range 0.27–80 µg mL-1; the regression coefficient was 0.996 and the linear regression equation was y = 48415x + 54359. The detection (LOD) and quantification (LOQ) limits were 0.086 and 0.2625 µg mL-1 respectively. The method was validated for accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. Statistical analysis proved the method was precise, reproducible, selective, specific, and accurate for analysis of CXB. The wide linearity range, sensitivity, accuracy, short retention time, and simple mobile phase imply the method is suitable for routine quantification of CXB with high precision and accuracy.

• Czasopismo: Acta Chromatographica
• Rocznik: 2007
• Tom: No. 18
• Strony: 116-129
• Opis fizyczny: Bibliogr. 24 poz., rys., tab.

Twórcy

autor

Baboota, S.

autor

Faiyaz, S.

autor

Ahuja, A.

autor

Ali, J.

autor

Shafiq, S.

autor

Ahmad, S.

• Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi-110062, India

Bibliografia

• [1] J. Fort, Am. J. Orthop., 28, 13 (1999)
• [2] A. Gaurl, A.M. Martel, and J. Castner, Drugs Future, 22, 711 (1997)
• [3] G.S. Gies, Scand. J. Rheumatol., 109, 31 (1999)
• [4] M.M. Goldberg, Clin. Ther., 21, 1497 (1999)
• [5] T. Kawamori, C.V. Rao, K. Seibert, and B.S. Reddy, Cancer Res., 58, 409 (1998)
• [6] S.M. Fisher, H.H. Lo, G.B. Gordon, K. Seibert, G. Kellof, R.A. Lubet, and C.J. Conti, Mol. Carcinog., 25, 231 (1999)
• [7] R.E. Harris, G.A. Alshafie, H. Asbou-Issa, and K Seibert, Cancer Res., 60, 2101 (2000)
• [8] R.N. Rao, S. Meena, and A.R. Rao, J. Pharm. Biomed. Anal., 39, 349 (2005)
• [9] R.N. Saha, C. Sajeev, P.R. Jadhav, S.P. Patil, and N. Srinivasan, J. Pharm. Biomed. Anal., 28, 741 (2002)
• [10] O.I. Wong, N. Tsuzuki, M. Rhichardson, M.H. Rytting, W.R. Konishi, and T. Higuchi, Heterocycles, 26, 315 (1987)
• [11] M.N.E.I. Kousy, J. Pharm. Biomed. Anal., 20, 185 (1999)
• [12] R.W. Mathew and F. Jamali, J. Chromatogr., 616, 59 (1993)
• [13] C. Giachetti, A. Assandri, G. Zalano, and E. Brembilla, Biomed. Chromatogr., 8, 180 (1994)
• [14] H.S. Chow, N. Anavy, D. Salazar, D.H. Frank, and D.S. Albert, J. Pharm. Biomed. Anal., 34, 167 (2004)
• [15] E. Stormer, S. Bauer, J. Kirehhiener, J. Brockmoller, and I. Roots, J. Chromatogr B, 783, 207 (2003)
• [16] M. Zhang, G.A. Moore, S.J. Gardiner, and E.J. Begg, J. Chromatogr B, 830, 245 (2006)
• [17] G. Jayasagar, M.K. Kumar, K. Chandrasekar, P.S. Prasad, and Y.M. Rao, Pharmazie., 57, 619 (2002)
• [18] M.A. Hamid, L. Novotny, and H. Hamza, J. Chromatogr. B, 753, 401 (2001)
• [19] U. Werner, D. Werner, A. Phal, R. Mundkowski, M. Gllich, and K. Brune, Biomed. Chromatogr., 16, 56 (2000)
• [20] U. Satyanarayana, D. Rao, Y.K. Kumar, J.M. Babu, P.R. Kumar, and J.T. Reddy, J. Pharm. Biomed. Anal., 35, 951 (2004)
• [21] F. Schoenberger, G. Hienkele, T.E. Murdter, S. Brenner, U. Koltz, and U. Hoffman, J. Chromatogr. B, 768, 255 (2002)
• [22] H. Jalalizadeh, M. Amini, V. Ziace, S.A. Farsam, and A. Shafice, J. Pharm. Biomed. Anal., 35, 665 (2004)
• [23] P.M. Dhabu and K.G. Akamanchy, Drug Dev. Ind. Pharm., 28, 815 (2002)
• [24] International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: Harmonised Triplicate Guideline on Validation of Analytical Procedures: Methodology, Recommended for Adoption at Step 4 of the ICH Process on November 1996 by the ICH Steering Committee, IFPMA, Switzerland