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| Determination of residual solvents in Naomaitong soft capsule by headspace GC |
| Hits 1895 Download times 1952 Received:June 20, 2011 |
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| DOI
10.11656/j.issn.1672-1519.2011.06.25 |
| Key Words
GC;residues of organic solvent;macroporous resin;Naomaitong |
| Author Name | Affiliation | | ZAHNG Zai-juan | Tianjin University of TCM, Tianjin 300193, China | | LU Di | College of Pharmacy of Henan University, Kaifeng 475001, China | | CUI Li-xia | Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China | | 马莉 | Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China | | 任晓文 | Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China |
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| Abstract
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| [Objective] To establish the method for analysis on organic solvent residues in Naomaitong soft capsule in order to provide the basis for quality assessment.[Methods] GC instrument coupled with headspace sampler was used and taking 50% of the aqueous solution of dimethylformamide as the solvent.The column was DB-624 capillary column(75 m×0.530 mm,df=3.00 μm);FID detector temperature was 250 ℃;A nitrogen flow rate was set at 15 mL/min in a constant flow mode;Oven temperature program was used from 50 ℃(18 min) to 80 ℃ at a rate of 100 ℃/min,then to 112 ℃ at a rate of 2 ℃/min,next to 160 ℃(10 min) at a rate of 100 ℃/min,finally to 200 ℃(5 min)at a rate of 100 ℃/min;Gasification chamber temperature was 250 ℃.The headspace vials were balanced at 90 ℃ for 40 min,the injection time was 1 min.[Results] The residual solvents were not detected in Naomaitong soft capsule.A good linear behavior was found in the concentration ranging from 0 to 40 μg/mL.The LODs were 0.2～2.8 μg/ml,the precisions RSD were less than 5.6%(n=5).The average recoveries were in the range from 18.8% to 48.3%,with RSD of 0.5%~8.9%(n=5).The components of reference solution were stable within 24 h(RSD,0.5%~8.9%,n=5).[Conclusion] The method is accurate,rapid and sensitive,so it can be used for controlling the organic residual solvents of Naomaitong. |
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