RP-HPLC法测定不同溶剂和缓冲溶液中羟基喜树碱的溶解度

Determination of equilibrium solubilities of HCPT in different solvents and phosphate buffer solutions

目的确定羟基喜树碱在不同溶剂和缓冲溶液中的平衡溶解度,为新型制剂的设计和制备奠定基础。方法采用高效液相色谱法测定羟基喜树碱在不同溶剂和缓冲溶液中的平衡溶解度。色谱条件:Diamonmsil-C18柱(4.6mm×250mm,5μm);流动相:甲醇-0.1mol/L磷酸盐缓冲液(60∶40),pH=5.0;流速:1mL/min;柱温:35℃;检测波长:384nm。结果首次确定了羟基喜树碱在16种溶剂和8种pH值的缓冲溶液中的溶解度。测定方法选择性较强,检测限为0.025mg/L,在0.050 6～10.120 0mg/L范围内峰面积与质量浓度呈良好的线性关系,精密度良好(RSD=0.13%),平均回收率为99.76%。结论测定结果为了解羟基喜树碱(HCPT)的理化性质及其新型制剂的设计和制备提供了科学依据,测定方法简便、迅速、准确。

Objective To determine equilibrium solubilities of HCPT in different solvents and phosphate buffer solutions which would settle fundament for the design and manufacture of a new dosage form. Methods HPLC was used to determine equilibrium solubilities （PBSs） of HCPT. HCPT was separated on Diamonsil-C18 column （4.6 mm× 250 mm, 5 μm） with methyl alcohol-0.1 mol/L phosphate buffer solution （60 ： 40）, pH= 5.0 as mobile phase. The flow rate was 1.0 mL/min and the detection wavelength was 384 nm. The column temperature was set at 35 ℃. Results The equilibrium solubilities of HCPT in 16 solvents and 8 PBSs with different pH values were gained firstly. The linear range for the content of HCPT was 0. 050 6-10. 120 0 mg/L. The recovery of HCPT was 99.76%, and its RSD was 0.13%. Conclusion The results in this study supplies a scientific reference for understanding the physicochemical properties of HCPT and the design and manufacture of its new dosage form. And the method was simple, rapid, and accurate.