RP-HPLC法测定拉坦前列素滴眼液中两种立体异构体杂质的含量

RP-HPLC determination of two stereoisomers in latanoprost eye drop

摘要: 建立拉坦前列素滴眼液中立体异构体杂质Ⅰ与杂质Ⅱ的含量测定方法。色谱柱为Zorbax SB-C₁₈(4.6 mm×250 mm，5 μm)，流动相为甲醇-乙腈-水(用冰乙酸调节pH 3.0)(56∶14∶30)，流速为1.0 mL/min，检测波长为210 nm，进样量为100 μL。在选定的色谱条件下，杂质Ⅰ、杂质Ⅱ与主成分可以有效分离，分别在0.049 99~0.999 8 g/mL、0.049 94~0.998 8 g/mL质量浓度范围内呈良好的线性关系，平均回收率分别为96.74%(n=9)与94.99%(n=9)。所建立的方法可以用于拉坦前列素滴眼液中立体异构体杂质Ⅰ与杂质Ⅱ的含量测定。

Abstract: To establish an HPLC method for the determination of impurity I and impurity II in latanoprost eye drop. HPLC separation was carried on a Zorbax SB- C₁₈ column(4. 6 mm250 mm, 5 m)with the mobile phase consisting of methanol-acetonitrile-water(adjusting pH to 3. 0 with acetic acid)(56 ∶14 ∶30). The flow rate was 1. 0 mL/min; the detection wavelength was 210 nm; and the injection volume was 100 μL. Impurity I, impurity II and latanoprost were separated efficiently under the selected HPLC conditions, with good linearity in the range of 0. 049 99-0. 999 8 g/mL for impurity I and 0. 049 94-0. 998 8 g/mL for impurity II. The average recoveries of impurity I and II were 96. 74%(n=9)and 94. 99%(n=9), respectively. The established method can be used for the detection of stereoisomers in latanoprost eye drop.