HPLC法测定酒石酸长春瑞滨脂质体注射液的含量

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,5 μm),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50 μL。 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 content determination of vinorelbine tartrate in liposome-encapsulated injection. Methods: The determination was performed on a Supecosil ABZ+Plus C₁₈(4.6 mm×150 mm,5 μm) column with the mobile phase consisting of 0.05 mol·L^-1 sodium dihydrogen phosphate solution(adjusted to pH 4.2 with phosphate acid)-0.2% sodium 1-decanesulfonate solution in methanol (40∶60) at a flow rate of 1.0 mL·min^-1;the detection wavelength at 267 nm,and the column temperature was 35 ℃. Results: Vinorelbine and its related substances were completely separated under selected chromatographic conditions,a good linear relationship was observed in the range of 0.02-0.06 mg·mL^-1 (r=0.9993);the recovery ranged from 99.3% to 100.1% (RSD=0.5%);the limit of detection was 1.7 ng.The sample determinations met the quality requirements. Conclusion: The method is simple,sensitive,specific and accurate,which can be used for quality control of vinorelbine tartrate liposome-encapsulated injection.

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