Abstract
ANALYSIS OF CELECOXIB IN HUMAN PLASMA WITH MEASUREMENT UNCERTAINTY ESTIMATION BY LIQUID CHROMATOGRAPHY–TANDEM MASS SPECTROMETRY

Suneetha Achanti* and Sharmila Nandavarapu

ABSTRACT

This paper describes a simple and rapid liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the quantification of celecoxib in human plasma using celecoxib d7 as internal standard (IS). A Zodiac C18 (50×4.6mm) 3.0μm column with isocratic mobile phase of 5mM ammonium formate buffer, acetonitrile and methanol (20:20:60,%v/v/v) was used at a flow rate of 1 mL/min. The proposed linearity for celecoxib was 5.047-2518.667 ng/mL. A total of five linearity curves were generated with quality control sample to calculate the precision and accuracy. Also the stability of analyte was extensively evaluated in plasma as well as in extracted samples and results met the acceptance criteria defined in USFDA guidelines. The chromatographic run time was set at 2.5 min which makes the proposed method high throughput. Intra- and inter-day precision defined by coefficient of variation was <10% and accuracy (bias %) was within 90–110%. Measurement uncertainty estimation was 11.2% for Celecoxib. The method has been successfully used for the analysis of celecoxib in human plasma.

Keywords: Celecoxib, Solid phase extraction, Method validation, LC-MS/MS, Measurement Uncertainty.


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