Introducing a full validated analyical procedure as an official compendial method for fentanyl transdermal patches

ABSTRACT

A simple, sensitive and specific HPLC method and also a simple and fast extraction procedure were developed for quantitative analysis of fentanyl transdermal patches. Chloroform, methanol and ethanol were used as extracting solvents with recovery percent of 92.1, 94.3 and 99.4% respectively. Fentanyl was extracted with ethanol and the eluted fentanyl through the C18 column was monitored by UV detection at 230 nm. The linearity was at the range of 0.5-10 microg/mL with correlation coefficient [r[2]] of 0.9992. 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 microg/mL, respectively. Other validation characteristics such as selectivity, robustness and ruggedness were evaluated. Following method validation, a system suitability test [SST] including capacity factor [k'], plate number [N], tailing factor [T], and RSD was defined for routine test