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

• 作者: Chunmin Wei Haibo Song Han Yao Ruichen Guo
• 来源期刊: 分析科学方法和仪器期刊(英文)
• 学科: 化学
• 关键词: POLICOSANOL Fatty ALCOHOLS GAS Chromatography-Mass Spectrometry GAS Chromatography-Hydrogen Flame IONIZATION Detector
• 年，卷（期）: fxkxffhyqqkyw_2012,（1）
• 页码范围: 24-28
• 页数: 5页
• 分类号: O6

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).