摘要
目的：用高效液相色谱法测定加巴喷丁胶囊的含量及有关物质。方法：采用Kromasil C8柱（250 mm×4.6 mm,5μm）;流动相：甲醇-0.01 mol·L-1磷酸二氢钾溶液（用2 mol·L-1氢氧化钾溶液调p H 6.9）（40∶60）;检测波长：210 nm;柱温：40℃;进样量：20μl。采用外标法测定主成分和已知杂质的含量,自身对照法测定未知杂质的含量。结果：加巴喷丁浓度在2.5～20.0 mg·ml-1范围内与峰面积呈良好的线性关系（r=0.999 9）。平均加样回收率为100.74%（RSD=0.24%,n=5）。结论：本方法快速、准确、专属性好,可用于加巴喷丁胶囊的含量及有关物质测定。
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.
出处
《中国药师》
CAS
2015年第3期520-522,共3页
China Pharmacist
