Abstract

GONZALEZ CANAVACIOLO, Víctor L; SIERRA PEREZ, Roxana  and  VELASQUEZ G, Caridad. Validation of a new capillary column GC analytical method for determining long chain fatty alcohols in policosanol active ingredient. Rev. colomb. cienc. quim. farm. [online]. 2008, vol.37, n.1, pp.62-68. ISSN 0034-7418.

Policosanol is a mixture of 8 long chain primary aliphatic alcohols (C24-C34), isolated and purified from sugar cane (Saccharum officinarum L.) wax, wich cholesterol-lowering efficacy, safety and tolerability has been demonstrated. Several methods for determing policosanol by packed GC column have been previously validated. However, the advantages achieved with the capillary GC make it worldwide currently extended and overcome to the packed ones. A new gas chromatographic method using a capillary column was developed and validated for the determination of the fatty alcohols that compose policosanol active ingredient. The alcohols were analyzed as trimethylsilyl derivatives. Good linearity (r2 = 0,9954, CVresponse=1,07%, CVslope=1,89% and the confidence interval included the zero, then there was no bias) and accuracy (mean recovery = 100,45%) of the method were proven over a range of 80-120% of the nominal concentration. It was also proved its specificity even when samples were subject to stress conditions. Repeatablility and intermediate precision at the nominal 100% value fulfilled the acceptance criteria (< 2%). Ruggedness was evaluated through an intralaboratory experimental design, in which seven operational changes were made, and there was not found any effect on the observed results. The method was sussefully validated being suitable for the quality control process and the stability studies of this active ingredient.

Keywords : Gas chromatography; long chain fatty alcohols; Policosanol; validation.

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