Validated HPLC method for analysis of oxaprozin in a formulation

• Autorzy: Ganesh M. , Thangabalan B. , Patil R. , Thakur D. , Saravana Kumar A. , Vinoba M. , Ganguly S. , Sivakumar T.
• Języki publikacji: EN

Abstrakty

EN

A rapid, simple and validated reversed-phase high-performance liquid chromatographic method has been developed for analysis of oxaprozin in pharmaceutical dosage forms. Oxaprozin was separated on an ODS analytical column with a 45:55 (v/v) mixture of acetonitrile and triethanolamine solution (5 mM, pH 3.5 š 0.05, adjusted by addition of 85% phosphoric acid) as mobile phase at a flow rate of 2.0 mL min^-1. The effluent was monitored by UV detection at 254 nm. Calibration plots were linear in the range 160 to 240 µg mL^-1 and the LOD and LOQ were 14.26 and 41.21 µg mL^-1, respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine QC determination of oxaprozin in tablets.

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2008
• Tom: Vol. 20, no. 2
• Strony: 165--173
• Opis fizyczny: Bibliogr. 14 poz., rys., tab.

Twórcy

autor

Ganesh M.

autor

Thangabalan B.

autor

Patil R.

autor

Thakur D.

autor

Saravana Kumar A.

autor

Vinoba M.

autor

Ganguly S.

autor

Sivakumar T.

• Nandha College of Pharmacy Department of Pharmaceutical Analysis Koorapalayam Pirivu Erode 638052 Tamil Nadu India Anna University Department of Chemical Engineering, Alagappa College of Technology Guindy, Chennai 600 025 Tamil Nadu India Birla Institute,

Bibliografia

• [1] Merck Research Laboratories, The Merck Index, An Encyclopedia of Chemical, Drugs, and Biologicals, 11th edn, Merck Research Laboratories, Whitehouse Station, NJ, 6879, USA, 2001, p. 1095
• [2] http://www.rxlist.com/oxaprozin
• [3] K.V.S.R.K. Reddy, D.S. Rao, K. Vyas, and G.O. Reddy, J. Pharm. Biomed. Anal., 22, 651 (2000)
• [4] D.M. Pierce, Xenobiotica, 11, 857 (1981)
• [5] F.W. Janssen, S.K. Kirkman, J.A. Knowles, and H.W. Ruelius, Drug Metab. Dispos., 6, 465 (1978)
• [6] L.S. McHugh, S.K. Kirkman, J.A. Knowles, and A. John, J. Pharm. Sci., 69, 794 (1980)
• [7] R. Matlis and D.J. Greenblat, J. Chromatogr., 445, 310 (1984)
• [8] M. Kruowski and H. Thobe, Agents Actions, 27, 458 (1989)
• [9] J.B. Gao, W. Hae, N.N. Zhang, and W. Wang, Chin. J. Pharm., 33(3), 132 (2003)
• [10] J.D. Johnson and G.E. Van Buskirk, J. Valid. Technol., 2, 88 (1998)
• [11] L.R. Snyder, J.J. Kirkland, and J.L. Glajch (Eds) Practical HPLC Method Development, Wiley–Interscience, New York, 1988, p. 402
• [12] International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Q2B (1996). Validation of Analytical Procedures, Methodology, pp. 1–8
• [13] US Pharmacopoeial Convention, United States Pharmacopoeia, 28th edn, US Pharmacopoeial Convention, Rockville, MD, 2005, pp. 1196-1198
• [14] FDA: Guidance for Industry, Analytical Procedures and Methods Validation, 2000.