DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING HPLC METHOD FOR ANALYSIS OF CELECOXIB (CXB) IN BULK DRUG AND MICROEMULSION FORMULATIONS

SUMMARY 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.