Determination of Gabapentin and Related Substances in Gabapentin Capsules by HPLC
- VernacularTitle:HPLC法测定加巴喷丁胶囊的含量及有关物质
- Author:
Li DONG
;
Jia DOU
;
Shuyu WANG
;
Shuang LUAN
;
Yingchun ZHAO
- Publication Type:Journal Article
- Keywords:
Gabapentin;
HPLC;
Content;
Related substances
- From:
China Pharmacist
2015;(3):520-522
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an HPLC method for the determination of gabapentin and the related substances in gabapentin capsules. Methods:A Kromasil C8 column (250 mm × 4. 6 mm,5μm)was used. The mobile phase was methanol-0. 01 mol·L-1 po-tassium dihydrogen phosphate solution (adjusting pH to 6. 9 with 2 mol·L-1 potassium hydroxide) (40∶60). The detection wave-length was 210 nm. The column temperature was 40℃ and the injection volume was 20μl. The main component and the known impuri-ty were determined by an external standard method. The unknown impurities were determined by a self-control method. Results: The calibration curve of gabapentin was linear within the range of 2.5-20.0 mg·ml-1(r=0.999 9). The average sample recovery was 100. 74% with RSD of 0. 24%(n=5). Conclusion:The method is simple, accurate,specific and applicable in the determination of gabapentin and the related substances in gabapentin capsules.