Development and Validation of a High-Performance Thin-Layer Chromatographic Method, with Densitometry, for Quantitative Analysis of Ketorolac Tromethamine in Human Plasma

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Abstract:

Ketorolac tromethamine is a potent nonsteroidal anti-inflammatory drug that is widely used in the treatment of moderate to severe pain. A new method was developed and validated for quantifying ketorolac (the free acid of the tromethamine salt) in human plasma by high-performance thin-layer chromatography. The stationary phase was silica gel 60, and the composition of the mobile phase was n-butanolchloroformacetic acidammonium hydroxidewater (9 3 5 1 2, v/v). The densitometric analysis of ketorolac was performed at 323 nm. The method was validated for precision (repeatability and reproducibility), accuracy, and sensitivity. Repeatability was 10.11% [coefficient of variation (CV)] and reproducibility was 12.18% (CV) as the maximum variation. Accuracy was determined at 3 different concentration levels, and results were within 15% of the predetermined range. Data were fitted by a linear mathematical function (linear regression). The calibration graph was linear in the range of 2002000 ng/mL. Average recovery was 73.67%. The method proved to be accurate, precise, and sensitive for the ketorolac tromethamine quantification.

Document Type: Research Article

Affiliations: 1: Fundacin Liomont A.C. privada Jess del Monte 77, Cuajimalpa, 05000, Mxico D.F. 2: Centro de Investigacin y de Estudios Avanzados (CINVESTAV) del IPN, Av. Instituto Politcnico Nacional 2508, San Pedro Zacatenco, 07360, Mxico D.F.

Publication date: September 1, 2008

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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