Validation of a gas chromatographic method for determination of fatty alcohols in 10 mg film-coated tablets of policosanol.

A gas chromatographic method using a packed column and 1-eicosanol as an internal standard was validated for the determination of the fatty alcohols that compose policosanol in 10 mg film-coated tablets. The alcohols were determined as trimethylsilyl derivatives, prepared with N-methyl-N-trimethylsilyltrifluoroacetamide. The method can detect degradation products with high retention times, without interfering with the peaks of the active principle. Good linearity (correlation coefficient = 0.9992) and accuracy (mean recovery -100.27 +/- 1.66%) were proven over a range of 25-200% of the nominal concentration. Within- and between-day precision at the nominal 100% value met the acceptance criteria (<2%). Ruggedness was examined through an intralaboratory experimental study in which 6 operational changes were made; the changes were found to have no effect on quantitation, repeatability, resolution, and relative retention time. The method is suitable for the quality control process and stability studies of these tablets.