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HPLC法测定加巴喷丁胶囊的含量及有关物质 被引量:2

Determination of Gabapentin and Related Substances in Gabapentin Capsules by HPLC
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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
关键词 加巴喷丁 高效液相色谱法 含量 有关物质 Gabapentin HPLC Content Related substances
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