HPLC法测定注射用硫酸头孢噻利的含量

摘要

Objective To establish a HPLC method for determination of the Cefoselis Sulfate. Methods The HPLC-UV method used Kromasil C18 (4.6 mm×250 mm, 5μm) column as an analytical column, a mobile phase consisted of 50 mmol•L-1 NaH2PO4-acetonitrile (90:10), at a lfow rate of 0.8 mL•min-1, and UV detection at 254 nm. The acetaminophen was used as internal standard. Results The assay was linear over the concentration range of 20~640μg•mL-1 (r=0.9999). The average recovery was (99.19±0.64)%. Intra-day and inter-day preci-sion showed coefifcients of variation within 0.78%(n=5) and 1.83%(n=5) over the three concentration levels. Conclusion The method is accurate, sensitive and simple, and can be used to detect the concentration of Cefoselis Sulfate.%目的：建立硫酸头孢噻利含量测定的反相高效液相色谱方法。方法采用HPLC-UV法测定，对乙酰氨基酚为内标，Kromasil C18柱（4.6 mm×250 mm，5μm）为分析柱，50 mmol•L-1磷酸二氢钠溶液-乙腈（90：10），流速为0.8 mL•min-1，检测波长为254 nm。结果头孢噻利在20～640μg•mL-1检测浓度范围内呈良好线性关系（r=0.9999），平均回收率为（99.19±0.64）%；日内差异RSD≤0.78%（n=5），日间差异RSD≤1.83%（n=5）。结论该方法操作简便、灵敏、准确，适用于头孢噻利的含量检测。