【摘要】：目的:建立陰離子交換色譜法測定鹽酸精氨酸注射液中氯的含量。方法:色譜柱為陰離子交換柱HAMILTON PRPX100(4.1 mm×250 mm,10μm),以0.1 mol·L-1硝酸鉀溶液1 000 m L,加甲醇500 m L和0.1 m L氫氧化四丁基銨溶液(10%),然后加水至5 000 m L為流動相,流速1.0 m L·min-1,檢測波長240nm,柱溫35℃,進樣量100μL。結(jié)果:Cl-1質(zhì)量濃度在0.034~0.272 mg·m L-1范圍內(nèi),線性關(guān)系良好(r=0.999 9),平均回收率(n=9)為99.1%,精密度、重復(fù)性、穩(wěn)定性均符合要求。81批樣品氯的測定結(jié)果為16.2%~17.6%。結(jié)論:本法經(jīng)方法學(xué)驗證,可作為鹽酸精氨酸注射液中氯含量質(zhì)量標準控制的方法。
[Abstract]:Objective: to establish anion exchange chromatography for the determination of chlorine in arginine hydrochloride injection. Methods: the chromatographic column consisted of anion exchange column HAMILTON PRPX100 (4.1 mm 脳 250 mm,10 渭 m),) with 0.1 mol L-1 potassium nitrate solution 1 000 mL, methanol 500 mL and 0.1 mL ammonium tetraDing Ji hydroxide solution (10%). The flow rate was 1.0 mL min-1, detection wavelength was 240 nm, column temperature was 35 鈩，

本文編號：2354692