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Determination of Residual Solvents in Rupatadine Fumarate by Headspace Gas Chromatography / 中国药师
China Pharmacist ; (12): 1024-1025,1026, 2016.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-604262
Responsible library: WPRO
ABSTRACT

Objective:

To determine the content of cyclohexane, ethyl acetate, methanol, methylene chloride and trichloromethane in rupatadine fumarate by headspace gaschromatography.

Methods:

A DB-WAXETRR capillary column(30 m × 0. 32 mm,0. 25 μm)was used and the carrier gas was nitrogen. The detector was an FID and the inlet temperature was 200℃ . The column temperature program was with the initial temperature of 35℃,maintained 10 min,and then risen to 220℃ with the rate of 20℃·min -1 ,and maintained 5 min.

Results:

Cyclohexane,ethyl acetate,methanol,methylene chloride and trichloromethane showed a good linear relationship within the range of 77. 590 1- 698. 310 9 μg·ml -1(r = 0. 999 7),102. 166 6- 919. 499 4 μg· ml -1(r = 0. 999 8),62. 744 7- 564. 703 2μg·ml -1(r = 0. 999 9),12. 011 2- 108. 101 1 μg·ml-1(r = 0. 999 6)and 1. 262 8-11. 365 6 μg·ml -1(r = 0. 999 6). The average recovery was 103. 9% ,103. 5% ,104. 9% ,107. 1% and 103. 4% and RSD was 2. 3% ,2. 6% ,3. 1% ,2. 8% and 4. 5%(n = 9),respectively. The five residual solvents were not detected out in rupatadine fumarate.

Conclusion:

The method is stable,simple,sensitive and accurate,and can be used for the determination of residual solvents in rupatadine fumarate.

Full text: Available Database: WPRIM (Western Pacific) Language: Chinese Journal: China Pharmacist Year: 2016 Document type: Article
Full text: Available Database: WPRIM (Western Pacific) Language: Chinese Journal: China Pharmacist Year: 2016 Document type: Article
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