HPLC法测定细菌溶解物（兰菌净）中的硫柳汞含量

目的 建立细菌溶解物（兰菌净）中硫柳汞的检测方法.方 法采用HPLC法对兰菌净中的硫柳汞进行含量测定.以Nova-pack ODS（3.6 mm×150 cm,4μm）色谱柱为固定相；甲醇-0.01 mol·L-1醋酸铵（冰醋酸调节pH4.5）为流动相进行梯度洗脱；流速为1 mL·min-1；检测波长为258 nm.结果 硫柳汞在0.1040～2.079 μg范围内与峰面积呈良好的线性关系,r＝0.9997.样品中硫柳汞的平均回收率为97.68％（n=9,RSD=1.36％）.硫柳汞定量限为0.01 μg.用本文建立的方法对5个批次兰菌净中的硫柳汞进行了测定,其含量为0.094～0.095 mg·mL-1.结论本方法准确可靠,可作为细菌溶解物（兰菌净）中硫柳汞的检测方法.

Determination of Thimerosal in Bacterial Lysates Vaccine Lantigen B by HPLC

Objective To develop a method for the thimerosal detection in bacterial lysates vaccine Lantigen B. Methods HPLC was adopted for the quantitative determination of thimerosal. A Nova-pack ODS column （3.6 mm×150cm, 4 μm） was used as the stationary phase, with a mobile phase consists of methanol and 0.01 mol · L^-1 ammonium acetate （adjusted to pH4.5 with acetic acid） in gradient elution mode, the flow rate was 1 min · L^-1, and the detection wavelength was set at 258 nm. Results Considerable linear relationship was observed when the thimerosal ranged from 0. 1040 to 2. 079 μg （r = 0.9997）. The average recoveries of thimerosal in Lantigen B was 97.68% （n=9, RSD=1. 36%）. The lower limit of quantitation was 0.01 μg. Five batches of Lantigen B were analyzed under the established method with results ranged from 0. 094 to 0. 095 mg· mL ^-1. Conclusion The developed method is accurate and reliable, which could be used for the quality control of thimerosal in Lantigen B.