INTRODUCING A FULL VALIDATED ANALYTICAL PROCEDURE AS AN OFFICIAL COMPENDIAL METHOD FOR FENTANYL TRANSDERMAL PATCHES

A simple, sensitive and specific HPLC method and also a simple and fast extraction procedure weredeveloped for quantitative analysis of fentanyl transdermal patches. Chloroform, methanol and ethanolwere used as extracting solvents with recovery percent of 92.1, 94.3 and 99.4% respectively. Fentanylwas extracted with ethanol and the eluted fentanyl through the C18 column was monitored by UVdetection at 230 nm. The linearity was at the range of 0.5-10 μg/mL with correlation coefficient (r2) of0.9992. Both intra and inter-day accuracy and precision were within acceptable limits. The detection limit(DL) and quantitation limit (QL) were 0.15 and 0.5 μg/mL, respectively. Other validation characteristicssuch as selectivity, robustness and ruggedness were evaluated. Following method validation, a systemsuitability test (SST) including capacity factor (k´), plate number (N), tailing factor (T), and RSD wasdefined for routine test.