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目的:建立HPLC法测定酒石酸长春瑞滨脂质体注射液中酒石酸长春瑞滨的含量。方法:采用Supecosil ABZ+Plus色谱柱(4.6 mm×150 mm,5μm),以0.05 mol·L-1磷酸二氢钠溶液(用磷酸调节pH至4.2)-0.2%癸烷磺酸钠的甲醇溶液(40∶60)为流动相,流速为1.0 mL·min-1,检测波长267 nm,柱温:35℃,进样量50μL。结果:在所选色谱条件下,主药与有关物质能较好分离,酒石酸长春瑞滨在0.02～0.06 mg·mL-1范围内,线性关系良好(r=0.9993);回收率范围为99.3%～100.1%(RSD=0.5%);检测限为1.7 ng;样品中含量测定符合质量要求。结论:该方法操作简便、灵敏、专属性强,准确度好,可用于酒石酸长春瑞滨脂质体注射液的质量控制。
Objective: To establish an HPLC method for the determination of vinorelbine tartrate in liposomal tartrate injection. METHODS: Supecosil ABZ + Plus column (4.6 mm × 150 mm, 5 μm) was used in a 0.05 mol·L-1 sodium phosphate monobasic solution (adjusted to pH 4.2 with phosphoric acid) to a 0.2% solution of sodium decanesulfonate in methanol (40:60) as the mobile phase, the flow rate was 1.0 mL · min-1, the detection wavelength was 267 nm, the column temperature was 35 ℃ and the injection volume was 50 μL. Results: Under the selected chromatographic conditions, the main drug and related substances could be separated well. The vinorelbine tartrate showed a good linear relationship (r = 0.9993) in the range of 0.02-0.06 mg · mL-1, the recovery range was 99.3% ~ 100.1% (RSD = 0.5%). The detection limit is 1.7 ng. The content of the sample meets the quality requirements. Conclusion: The method is simple, sensitive, specific and accurate. It can be used for the quality control of vinorelbine tartrate injection.