Quality Evaluation of Policosanol Film-Coated Tablets by Simultaneous Determination of Eight Ingredients Using GC- FID and GC-MS
- 1 School of Pharmacy, Shandong University, Jinan, P.R.China
- 2 Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, P.R.China
- 3 Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, P.R.China
- 4 Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, P.R.China
Abstract
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).
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