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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 determine the content of gabapentin capsules and related substances by high performance liquid chromatography. METHODS: Kromasil C8 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of methanol-0.01 mol·L-1 potassium dihydrogen phosphate solution (pH 6.9 with 2 mol·L -1 potassium hydroxide solution) 40:60); detection wavelength: 210 nm; column temperature: 40 ℃; injection volume: 20μl. External standard method was used to determine the content of the main components and the known impurities, and the self-control method was used to determine the content of the unknown impurities. Results: The concentration of gabapentin showed a good linear relationship with the peak area in the range of 2.5-20.0 mg · ml-1 (r = 0.999 9). The average recovery was 100.74% (RSD = 0.24%, n = 5). Conclusion: The method is rapid, accurate and specific, and can be used for the determination of gabapentin capsules and related substances.