复方醋酸钠林格注射液质量标准研究

Quality Standard of Compound Sodium Acetate Ringer Injection

目的 建立统一完善复方醋酸钠林格注射液的质量标准。方法 采用化学反应对离子进行定性鉴别;采用分光光度法测定5-羟甲基糠醛;采用高效液相色谱法测定无水葡萄糖含量,色谱柱为Waters XBridge Amide(250 mm×4.6 mm,5μm),流动相为乙腈-水-氨水(75∶25∶0.1),示差折光检测器,柱温和检测器温度为40℃。采用高效液相色谱法测定醋酸钠和枸橼酸钠含量,色谱柱为Waters T3 C_(18)(250 mm×4.6 mm,5μm)流动相为磷酸盐缓冲液-甲醇(95∶5),柱温为30℃,检测波长为210 nm,流速为1 mL·min^(-1)。结果 化学鉴别和5-羟甲基糠醛测定均能满足标准要求。无水葡萄糖、醋酸钠和枸橼酸钠分别在0.412 5~8.249、0.167 4~6.697、0.029 42~1.177 mg·mL^(-1)浓度范围内与峰面积线性关系良好,精密度、稳定性等试验的RSD均小于2.0%,平均回收率分别为100.5%、99.5%、99.7%,RSD分别为0.5%、0.4%、0.5%(n=9)。结论 该研究中建立的方法操作简便、稳定可靠,可用于复方醋酸钠林格注射液质量标准的建立及质量控制。

OBJECTIVE To establish the quality standard of compound sodium acetate ringer injection.METHODS Chemical reactions were used for qualitative identification of ions.Spectrophotometric determination was used for content of 5-Hydroxymethylfurfural.The content of anhydrous glucose was determined by high performance liquid chromatography.The method was established by using Waters XBridge Amide(250 mm×4.6 mm,5 μm).The mobile phase was acetonit Rile-water-ammonia(75∶25∶0.1).Differential refractive index detector was used to determine the anhydrous glucose,and the column temperature and detector temperature of 40 ℃.The content of sodium acetate and sodium citratein were determined by high performance liquid chromatography.Themethod was established by using Waters T3 C_(18)(250 mm×4.6 mm,5 μm).The mobile phase was phosphate buffer solution-methanol(95∶5).The column temperature was 30 ℃,the detection wavelength was 210 nm,the flow rate was 1 mL·min^(-1).RESULTS Chemical identification and 5-hydroxymethylfurfural determination met the standard requirements.The linear ranges of anhydrous glucose,sodium acetate,and sodium citrate were 0.412 5-8.249 mg·mL^(-1),0.167 4-6.697 mg·mL^(-1),and 0.029 42-1.177 mg·mL^(-1),respectively.The RSD sof precisionand stability were all less than 2.0%,and the average recoveries were 100.5%,99.5%,and 99.7%,respectively.The RSDs were 0.5%,0.4%,and 0.5%,respectively(n=9).CONCLUSION The method established in this study is simple,stable,and reliable,and can be used for the quality control of compound sodium acetate ringer injection.