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目的建立高效液相色谱法测定重组人胰高血糖素类多肽-1(7-36)注射液中苯酚含量的方法。方法采用C18烷基硅烷键合硅胶色谱柱(Venusil XBP-C18 5um 100A 4.6×250mm),流动相A:甲醇(HPLC),流动相B:超纯水,流速:1m L/min,柱温为25℃,进样量为10μL,波长269nm。结果精密度试验RSD为0.086%(n=6);苯酚的浓度在0.044 mg/m L-0.44 mg/m L范围内与峰面积有良好的线性关系(R2>0.9999);平均回收率为99.20%(n=9);不同色谱条件下,耐用性良好。结论该方法快速、简便、重复性好,适用于重组人胰高血糖素类多肽-1(7-36)注射液中苯酚含量的测定。
Objective To establish a method for the determination of phenol in recombinant human glucagon-like peptide-1 (7-36) injection by high performance liquid chromatography. Methods A C18 alkylsilane bonded silica gel column (Venusil XBP-C18 5um 100A 4.6 × 250 mm) was used. The mobile phase A was methanol (HPLC), the mobile phase B was ultrapure water, the flow rate was 1 mL / 25 ℃, injection volume of 10μL, wavelength 269nm. Results The RSD of precision test was 0.086% (n = 6). There was a good linear relationship between the phenol concentration and peak area in the range of 0.044 mg / m L-0.44 mg / m L (R2> 0.9999). The average recovery was 99.20 % (n = 9); Durability is good under different chromatographic conditions. Conclusion The method is rapid, simple and reproducible. It is suitable for the determination of phenol in recombinant human glucagon-like peptide-1 (7-36) injection.