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| Validation of Determination Method of Residual Solvents in Gabapentin |
| WEI Jun-qing, ZHANG Meng, ZHAO Dong-ming |
| The Research and Development Department of CSPC Ouyi Pharmaceutiacal Corporation Ltd., Shijiazhuang 050000,China |
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Abstract Gabapentin is an anti-epilepsy drug and a gamma aminobutyric acid.It was first developed by Warner-Lanbert in the USA, it was first listed in UK in 1993. In gabapentin production,there were some residual solvents including dichloromethane, methanol, ethanol, ethyl acetate and isopropyl alcohol in the product,so they should be controlled strictly. According to Q3C of the ICH about the residual solvents, the analysis method of the residual solvents of gabapentin was validated by gas chromatography with headspace sampling. The validation results showed that the method had high precision and good linearity, could meet the needs of quality control of drugs.
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