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目的建立高效液相色谱(HPLC)法测定左旋盐酸去甲苯环壬酯渗透泵片的含量和有关物质。方法采用C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.05 mol/L醋酸钠缓冲液(85∶15,pH 6.0)为流动相,检测波长为220 nm,流速为1.0 ml/min,柱温为40℃。结果在优化的色谱条件下,左旋盐酸去甲苯环壬酯与有关物质可有效分离,辅料和溶剂不干扰主药测定;主药的线性范围为30.0～200.0μg/ml(r=0.9998);平均回收率为99.52%,RSD为0.94%(n=9)。结论该方法简便准确,专属性强,可用于测定左旋盐酸去甲苯环壬酯渗透泵片的含量和有关物质。
OBJECTIVE To establish a HPLC method for the determination of content and related substances of L-norcyclohexylnone hydrochloride osmotic pump tablets. Methods The mobile phase was acetonitrile-0.05 mol / L sodium acetate buffer (85:15, pH 6.0) with a C18 column (250 mm × 4.6 mm, 5 μm) at a detection wavelength of 220 nm and a flow rate of 1.0 ml / min The column temperature was 40 ℃. Results Under the optimized chromatographic conditions, the cyclodextrin and its related substances could be effectively separated, and the adjuvants and solvents did not interfere with the determination of the main drug. The linear range of the main drug was 30.0 ~ 200.0μg / ml (r = 0.9998) The recovery was 99.52% with a RSD of 0.94% (n = 9). Conclusion The method is simple, accurate and specific. It can be used to determine the content and related substances of levonorgestrel hydrochloride osmotic pump tablets.