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目的:改进2010年版《中国药典》所载远志中远志酮Ⅲ含量测定的方法。方法:采用高效液相色谱法。色谱柱为Hypersil BDS C18,流动相为乙腈-0.05%磷酸(梯度洗脱),流速为1.0 ml/min,检测波长为320 nm,柱温为25℃,进样量为10μl。结果:远志酮Ⅲ检测质量浓度线性范围为0.029~0.928μg/ml(r=0.999 1);精密度、稳定性、重复性试验的RSD<2%;加样回收率为94.66%~100.90%(RSD=2.46%,n=6)。结论:该方法操作简便、稳定、重复性好,虽测定时间有所延长,但提高了测定的准确度,更适用于远志中远志酮Ⅲ的含量测定。
OBJECTIVE: To improve the method for the determination of ketones Ⅲ in Polygalaceae contained in the 2010 edition of “Chinese Pharmacopoeia”. Methods: Using high performance liquid chromatography. The chromatographic column was Hypersil BDS C18. The mobile phase consisted of acetonitrile-0.05% phosphoric acid (gradient elution), the flow rate was 1.0 ml / min, the detection wavelength was 320 nm, the column temperature was 25 ℃ and the injection volume was 10μl. Results: The linear range of the concentration of prochlorazone Ⅲ was 0.029-0.928 μg / ml (r = 0.999 1). The RSD of precision, stability and reproducibility was less than 2%, and the recoveries were 94.66% -100.90% RSD = 2.46%, n = 6). Conclusion: The method is simple, stable and reproducible. Although the determination time is prolonged, the method can improve the accuracy of determination and is more suitable for the determination of.