高效液相色谱法测定注射用盐酸头孢吡肟中精氨酸含量

目的 改进中国药典2010年版中注射用盐酸头孢吡肟中精氨酸的含量测定方法.方法 采用Agilent Extend-C18柱（5μm,4.6×250mm）,含0.015mol·L-1辛烷磺酸钠的0.1mol·L-1的磷酸二氢钠 （用氢氧化钠试液调节pH值至5.0）-甲醇（94：6）为流动相,流速：1.0mL·L-1,检测波长206nm,精氨酸浓度为0.1mg·mL-1,柱温控制在40℃.结果 克服了原方法中精氨酸峰形严重拖尾问题;本方法中精氨酸在0.3μg～1.4μg范围内,线性关系较好（r=0.9977）,平均回收率为99.17%,RSD为1.8%.结论 方法可用于注射用盐酸头孢吡肟中精氨酸的含量测定,结果准确可靠.

Determination of Arginine in Cefepime Hydrochloride for Injection by RP-HPLC

OBJECTIVE To improve an RP-HPLC method for determination of Arginine in Cefepime Hydro- chloride of Chinese pharmacopoeia,2010 edition. METIIOI）S The determination was performed on octadeeysilane chemically boned silica column, the mobile phase was composed of 0. 1 mol · L-1 Sodium Dihydrogen Phosphate con- tained 0. 015mol · L-1 Sodium Oetanesulfonate （adjusted to pH 5.0 with Sodium Hydroxide test solution）-methanol （94：6） ,and the flow rate was 1.0mL · min-1 ,column temperature was 40℃ ,the detection was carried out with UV =0. 9977） ,the average recoveries were 99. 17% ,RSD were 1.8%. CONCLUSION the test shows that this meth- od is suitable for the assay of Arginine in Cefepime Hydrochloride for injection and can acquires the accurate and re- liable data.