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目的建立盐酸左旋去甲基苯环壬酯(demethyl levophencynonate hydrochloride,L-LPC)片的含量及有关物质的分析方法。方法采用高效液相色谱法;色谱柱Capcel PAK C18柱,MGⅡ5μm,4.6 mm×250 mm,Col:No.A4AD 02992(Shiseido,日本);流动相甲醇∶乙腈∶0.05 mol/L醋酸钠缓冲溶液(pH 5.0)为4∶3∶3;流速1.0 ml/min;检测波长220 nm;进样量20μl;柱温为室温。结果方法回收率为(100.15±0.73)%;溶液在8 h保持稳定(RSD为0.36%);在0.1~50μg/ml范围内线性关系良好,其回归方程为Y=81558X-4768.3(R2=1,n=3)。结论所建立的方法简便、准确、灵敏,专属性强,为该制剂含量测定、半成品测定及制剂稳定性研究提供了方法学依据。
Objective To establish a method for the determination of demethyl levophencynonate hydrochloride (L-LPC) tablets and its related substances. Methods Columns: Capcel PAK C18, MGⅡ5μm, 4.6 mm × 250 mm, Col: No.A4AD 02992 (Shiseido, Japan); mobile phase methanol: acetonitrile: 0.05 mol / L sodium acetate buffer solution pH 5.0) was 4: 3: 3, the flow rate was 1.0 ml / min, the detection wavelength was 220 nm, the injection volume was 20μl, and the column temperature was room temperature. Results The recovery rate was (100.15 ± 0.73)%. The solution was stable at 8 h (RSD 0.36%). The linearity was good in the range of 0.1-50 μg / ml. The regression equation was Y = 81558X-4768.3 , n = 3). Conclusion The established method is simple, accurate, sensitive and specific. It provides a methodological basis for the determination of the content, the determination of semi-finished products and the study of formulation stability.