HPLC法测定盐酸溶菌酶片的含量

目的建立HPLC法测定盐酸溶菌酶的含量。方法采用Agilent ODS柱（150mm×4．6mm，5μm）为色谱柱；以：三氟乙酸溶液（取三氟乙酸1ml，用水稀释至1000ml，滤过并脱气）-乙腈溶液（取乙腈900ml，加水100ml，再加入三氟乙酸1ml，滤过并脱气）为流动相，梯度洗脱；流速1．0ml/min，检测波长276nm。结果盐酸溶菌酶在270．0～630．0μ/ml的范围内线性良好，r=0．9992，平均回收率为100．4％，RSD=0．8％（n=9）。结论该方法简单、准确可靠，可用于盐酸溶菌酶片的质量控制。

Content Determination of Lysozyme Hydrochloride Tablets by HPLC

Objective To establish an HPLC method for the content determination of Lysozyme Hydrochloride tablets Methods The Agilent ODS column （ 150mm×4.6mm,5μm） was used, with trifluoroacetic acid solution （ 1 ml, diluted to 1 000 ml with water, filtrated and degassed）-acetonitrile solution （900 ml, with 100 ml water and 1 ml trifluoroacetic acid solution, filtrated and degassed） as a mobile phase, with gradient elution at a flow rate of 1.0 ml/min. The detection wavelength was 276 nm. Results The linear range of Lysozyme Hydrochloride was 270.0 - 630.0 Ixg/ml （r = 0. 999 2）. The average recovery was 100.4% （ RSD = 0.8% ）. Conclusion The method is simple, reliable, accurate, and can be suitable for quality control of Lysozyme Hydrochloride tablets.