高效液相色谱法测定复方氨基酸注射液(9AA)中抗氧剂的含量

Determination of antioxidants in Compound Amino Acids Injection(9AA)by HPLC

目的建立高效液相色谱(HPLC)测定复方氨基酸注射液(9AA)中抗氧剂焦亚硫酸钠与L-盐酸半胱氨酸含量的方法。方法采用HPLC法测定。强酸型阳离子交换柱(磺化苯乙烯-二乙烯基苯共聚物),以0.04 mol/L磷酸溶液为流动相,柱温为50℃,检测波长为200 nm,测定焦亚硫酸钠的含量;采用C18柱,以二硫代二丙酸为氧化剂,异硫氰酸苯酯柱前衍生化,梯度洗脱,检测波长为254 nm,测定L-盐酸半胱氨酸的含量。结果焦亚硫酸钠和L-盐酸半胱氨酸分别在0.04～0.36和4.24～38.12 mg/L范围内线性关系良好,回收率分别为98.6%和99.6%,RSD分别为0.90%和1.5%(n=9)。结论建立了准确高效的焦亚硫酸钠与L-盐酸半胱氨酸的HPLC测定方法,为质量标准的提高提供依据。

Purpose To establish HPLC methods for the determination of antioxidant sodium pyrosulfite and L-cysteine hydrochloride monohydrate in Compound Amino Acids Injections （9AA）. Methods The MKF-CIS chromatograph column was used with the mobile phase of 0.04 mol/L H3PO4. The detection wavelength was 200 nm to determine the content of the sodium pyrosulfite. A C18 column was used for HPLC method with PITC preeolumn derivation,DTDPA as oxidant agent and determing L-eysteine hydro- chloride monohydrate at 254 nm. Results The calibration curves of the two components were 0.04-0.36 mg/mL （ sodium pyrosulfite） and 4.24-38.12 mg/L （cysteine） respectively. Their recoveries were 98.6% and 99.6% ,with RSD of 0.90% and 1.5% （n = 9）,respectively. Conclusion The methods can accu- rately and efficiently determine sodium pyrosulfite and cysteine so as to improve the quality of injection.