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目的:建立测定琥珀酰明胶注射液中游离琥珀酸及琥珀酰化度的高效液相色谱法。方法:采用Agilent Zorbax 300SBC18色谱柱(4.6mm×250mm,5μm),流动相为乙腈-0.02mol·L-1磷酸二氢钾缓冲液(p H 2)(5∶95),流速0.6mL·min-1,柱温20℃,检测波长210nm。结果:分离度良好,满足定量测定要求,线性范围为30~480μg·mL-1,加样平均回收率均大于90%,琥珀酰明胶注射液样品中游离琥珀酸含量小于200mg·L-1,琥珀酰化度为1.9%,均符合要求。结论:建立的方法简便快速,重复性好,精密度高,可用于测定琥珀酰明胶注射液中游离琥珀酸及琥珀酰化度。
OBJECTIVE: To establish a HPLC method for determination of succinic acid and succinylation in succinyl gelatin injection. METHODS: Agilent Zorbax 300SBC18 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase consisted of acetonitrile-0.02 mol·L-1 potassium dihydrogen phosphate buffer (pH 2) (5:95) -1, column temperature 20 ℃, detection wavelength 210nm. Results: The separation was good and the quantitative determination was satisfactory. The linear range was 30 ~ 480μg · mL-1, the average recoveries were more than 90%, and the succinic acid content in succinyl gelatin injection was less than 200mg · L-1. Succinate degree of 1.9%, all in line with the requirements. Conclusion: The established method is simple and rapid, good repeatability and high precision. It can be used to determine succinic acid succinate and succinylation in succinyl gelatin injection.