Quality Evaluation of Policosanol Film-Coated Tablets by Simultaneous Determination of Eight Ingredients Using GC- FID and GC-MS  

作　　者：Han Yao Chunmin Wei Haibo Song Ruichen Guo 

机构地区：[1]Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, P.R.China [2]School of Pharmacy, Shandong University, Jinan, P.R.China

出　　处：《Journal of Analytical Sciences, Methods and Instrumentation》2012年第1期24-28,共5页分析科学方法和仪器期刊（英文）

摘　　要：A new and simple gas chromatographic (GC) method using flame ionization detector (FID) and mass spectrometry (MS) for the simultaneous determination of eight fatty alcohols in 10 mg policosanol film-coated tablets was established and applied to the quality control (QC) of policosanol film-coated tablets. A DB-35MS capillary column (30 m × 0.32 mm, 0.25 um) was employed for the separation. GC-FID was used to quantitatively analyze the eight ingredients with 1-eicosanol as internal standard, three of which were identified using GC-MS due to the lack of standard. The linearity, accuracy, precision, stability, robustness and sensitivity within the detection limits were evaluated. The average recovery of the method was 96.3-100.4% and linearity was (R > 0.999). The average drug content was found to be 96.8% of the labeled amount (10 mg).A new and simple gas chromatographic (GC) method using flame ionization detector (FID) and mass spectrometry (MS) for the simultaneous determination of eight fatty alcohols in 10 mg policosanol film-coated tablets was established and applied to the quality control (QC) of policosanol film-coated tablets. A DB-35MS capillary column (30 m × 0.32 mm, 0.25 um) was employed for the separation. GC-FID was used to quantitatively analyze the eight ingredients with 1-eicosanol as internal standard, three of which were identified using GC-MS due to the lack of standard. The linearity, accuracy, precision, stability, robustness and sensitivity within the detection limits were evaluated. The average recovery of the method was 96.3-100.4% and linearity was (R > 0.999). The average drug content was found to be 96.8% of the labeled amount (10 mg).

关 键 词：POLICOSANOL FATTY ALCOHOLS GAS Chromatography-Mass Spectrometry GAS Chromatography-Hydrogen Flame Ionization Detector 

分 类 号：O6[理学—化学]