The present article describes the development and validation of a Gas Chromatographic method for the confirmation of octacosanol in the mixture of policosanol. Literature cites the percentage of octacosanol in policosanol mixture to be up to 85% and no isomers have been reported as date. A gas chromatographic method using a packed column was developed and validated for determination of fatty alcohols in policosanol predominantly octacosanol. Typical concentration considered for this study was 0.1mg/ml or 100 PPM based on the range assay between 0.02mg/ml (20ppm) and 0.12mg/ml (120ppm). The validation steps included the verification of linearity, repeatability, specificity, recovery, reproducibility, stability and ruggedness in the samples. The method can detect degradation products and has good linearity (correlation coefficient 0.99) in a range of 20ppm to 150ppm (20% - 120%) and accuracy (recovery = 100.07 -101%). The nominal concentration considered for this method is 0.1mg/ml (100 ppm). The recoveries demonstrated in this method are 100.6% lowest at 120% and 50% of standard concentration and 101.6% at level of 100% of the standard (nominal) concentration with RSD not more than 2%. System precision and intermediate precision RSD was found to be not more than 2% while in intermediate precision the ratio between two determinations was found to be in between 0.97 and 1.03 Robustness was examined by changing operational parameters with RSD not more than 1%. Repeatability and reproducibility were obtained at a uniform level. These findings suggest good reproducibility and can be suitable for analyzing compositions containing policosanol for quality control and stability studies. The results of the validation process revealed that the proposed method is suitable for reliable quantification and confirmation of octacosanol content in the policosanol mixture and for analysis of tablets therein. The method is intended to be used for determination and identification/confirmation of octacosanol in policosanol (Assay determination) and capable of detecting degradation products, but may not be capable to resolve the individual impurities or degradation products.
Loading....