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目的系统地比较高效毛细管电泳法(HPCE)和高效液相色谱法(HPLC)在测定科博肽注射液含量方面的差异。方法HPCE分离条件为:未涂层毛细管柱(50μm×40 cm,有效长度30 cm),运行缓冲液为0.1 mol·L-1磷酸盐缓冲液(p H 2.5),分离电压20 k V,柱温25℃,检测波长200 nm;HPLC分离条件为:Aeris PEPTIDE XB-C18柱(4.6 mm×150 mm,3.6μm),柱温30℃,流速0.9 m L·min-1,检测波长200 nm,流动相A:0.1%三氟乙酸-水、流动相B:0.1%三氟乙酸-乙腈,梯度洗脱。结果科博肽在HPLC和HPCE各自的分离条件下进样浓度分别在17.33~138.60μg·m L-1、1.08~138.60μg·m L-1内表现出良好的线性关系(r均为0.999 7),平均加样加收率分别为100.3%和99.3%,RSD分别为0.7%和1.2%。结论 HPCE与HPLC均可用于科博肽注射液的含量测定,但HPCE在使用成本、分离时间、检出限等方面更具有优势。
OBJECTIVE: To systematically compare the differences between high performance capillary electrophoresis (HPCE) and high performance liquid chromatography (HPLC) in the determination of the content of Cobotine injections. Methods The separation conditions of HPCE were: uncoated capillary column (50 μm × 40 cm, effective length 30 cm), running buffer 0.1 mol·L-1 phosphate buffer (p H 2.5), separation voltage 20 k V, column And the detection wavelength was 200 nm. The conditions for the HPLC separation were: Aeris PEPTIDE XB-C18 column (4.6 mm × 150 mm, 3.6 μm), the column temperature was 30 ℃, the flow rate was 0.9 m L · min-1, Mobile phase A: 0.1% trifluoroacetic acid-water, mobile phase B: 0.1% trifluoroacetic acid-acetonitrile, gradient elution. Results The concentration of Cobotine in HPLC and HPCE was 17.33 ~ 138.60μg · m L-1, 1.08-138.60μg · m L -1, respectively, and the linearity was 0.999 7 ), With the average addition rates of 100.3% and 99.3% respectively, with RSDs of 0.7% and 1.2% respectively. Conclusion Both HPCE and HPLC can be used for the determination of Cobotine injection, but HPCE has more advantages in terms of cost, separation time and detection limit.