HPLC法测定重酒石酸长春瑞滨脂质体注射液中的溶血卵磷脂

Determination of lysolecithin in vinorelbine bitartrate liposome injection by HPLC

目的建立重酒石酸长春瑞滨脂质体注射液中溶血卵磷脂1-palmitoyl-2-hydroxy-sn-glycero-3-phosphocholine.(P-lyso-PC)和1-stearoyl-2-hydroxy-sn-glycero-3-phosphocholine(S-lyso-PC)含量测定的HPLC法。方法色谱柱:Waters XTerra MS C18柱(4.6 mm×150 mm,3.5μm),流动相:甲醇-0.02 mo.lL-1的草酸溶液(体积比为85∶15),流速:1.0 mL.min-1,柱温:35℃,示差折光检测器,进样量:100μL。结果重酒石酸长春瑞滨不干扰溶血卵磷脂的检测,P-lyso-PC质量浓度在0.04～0.40 g.L-1内与峰面积呈良好线性关系(r=0.999 7);S-lyso-PC质量浓度在0.04～0.40 g.L-1内与峰面积呈良好线性关系(r=0.999 3),平均回收率分别为98.5%(n=9)和99.1%(n=9)。结论本方法适用于重酒石酸长春瑞滨脂质体注射液中的溶血卵磷脂的质量控制。

Objective To establish an HPLC method for determination of lysolecithin which contains 1-palmitoyl-2-hydroxy-sn-glycero-3-phosphocholine （ P-lyso-PC ） and 1-stearoyl-2-hydroxy-sn-glycero-3-phosphocholine（S-lyso-PC） in vinorelbine bitartrate liposome injection. Methods The determination was performed with a C18 chromatographic column. The mobile phase was methanol and 0. 02 mol-L-1 oxalic acid（ V： V=85： 15） at a flow rate of 1.0 mL .min-1. The column temperature was set at 35 ℃ and the sample size was 100 μL. Results Vinorelbine bitartrate has no interference with the analysis of lysolecithin under the chroma- tographic condition mentioned above. The linear range was 0. 04- 0. 40 g. L - 1 （ r = 0. 999 7 ） for P-lyso-PC and 0. 0443. 40 g. L-1 （ r = 0. 999 3 ） for S-lyso-PC. The average recoveries of P-lyso-PC and S-lyso-PC were 98.5 % （ n = 9 ） and 99. 1% （ n = 9 ）, respectively. Conclusions The method is found to be simple and accurate for simultaneous analysis of P-lyso-PC and S-lyso-PC in vinorelbine bitartrate liposome, and provides a reliable way for evaluating the quality of it.