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Determination of Seven Residual Solvents in Cinnarizine Tablets and Its Raw Materials and Excipients

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Author:
No author available
Journal Title:
Drug Evaluation
Issue:
4
DOI:
10.19939/j.cnki.1672-2809.2024.04.07
Key Word:
桂利嗪;残留溶剂;气相色谱法;Cinnarizine;Residual solvent;Gas chromatography

Abstract: Objective To establish a method for determination of residual solvents including ethanol,acetone,isopropanol,n-hexane,triethylamine,n-heptane and tolnene in cinnarizine tablets and cinnarizine raw materials and excipients.Methods Chromatographic column was DB-624(60 m×0.32 mm×1.80 μm),with FID detector,the direct injection,temperature programmed,with nitrogen as carrier;the residues of seven organic solvents in 148 batches of cinnarizine tablets,14 batches of cinnarizine raw materials and 10 batches of excipients were determined.Results Seven residual organic solvents well separated efficiently by GC,with good linearity within the observed concentration range,and the correlation coefficient were are 0.998 3,0.998 5,0.998 4,0.998 9,0.999 4,0.999 4 and 0.998 6 respectively,the average recoveries were 95.8%,96.4%,98.5%,94.4%,97.4%,96.2%and 99.1%respectively.Conclusion The method is sensitive and accurate with good stability,which can be used to detection of residual solvents preparations and apis.This method is sensitive,accurate and reproducible,and can be used for the detection of residual solvents in preparations,raw materials and excipients.

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