Development and validation of a high-performance thin-layer chromatographic method, with densitometry, for quantitative analysis of ketorolac tromethamine in human plasma.
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-butanol-chloroform-acetic acid-ammonium hydroxide-water (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 200-2000 ng/mL. Average recovery was 73.67%. The method proved to be accurate, precise, and sensitive for the ketorolac tromethamine quantification.
López-Bojórquez
Ericka
E
Fundación Liomont A.C. privada Jesús del Monte 77, Cuajimalpa, Mexico D.F.
Castañeda-Hernández
Gilberto
G
González-de la Parra
Mario
M
Namur
Salvador
S
D000286:Administration, Sublingual; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000097:blood*; D002138:Calibration; D002855:Chromatography, Thin Layer; D003720:Densitometry; D006801:Humans; D007202:Indicators and Reagents; D020911:Ketorolac Tromethamine / Q000097:blood*; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013607:Tablets / Q000032:analysis
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007202:Indicators and Reagents; D012996:Solutions; D013607:Tablets; D020911:Ketorolac Tromethamine