论文部分内容阅读
目的:建立测定胆维丁原料药及其有关物质含量的方法。方法:采用高效液相色谱法,参照《中国药典》2010年版二部中维生素D3和胆固醇的含量测定项下方法测定胆维丁中2种成分的含量,其中胆固醇测定时由《中国药典》的蒸发光散射检测器改为二极管阵列检测器,并进行方法学考察。维生素D3和有关物质含量测定的色谱柱为PhenomenexLuna5μmSilica(2),流动相为正己烷-正戊醇(997:3),测定波长为254nm,流速为2·5mL·min-1;胆固醇测定的色谱柱为WatersSunfireC18,流动相为甲醇,检测波长205nm,流速为1·0mL·min-1。结果:胆固醇检测浓度线性范围为51·15～511·5μg·mL-1(r=0·9999),平均回收率为98·75%(RSD=0·94%)。结论:建立的方法准确、可靠,能有效控制胆维丁原料药的质量。
Objective: To establish a method for determining the content of gallbladder Ding material and its related substances. Methods: The HPLC method was used to determine the contents of two components in gallbladder D in accordance with the determination of vitamin D3 and cholesterol in the second edition of Chinese Pharmacopoeia (2010 edition). The content of cholesterol, Evaporative light scattering detector to diode array detector, and methodological study. The chromatographic column for the determination of vitamin D3 and related substances was Phenomenex Luna 5 μm Silica (2), the mobile phase was n-hexane-n-amyl alcohol (997: 3), the detection wavelength was 254 nm and the flow rate was 2.5 mL · min -1. Column WatersSunfireC18, mobile phase methanol, detection wavelength 205nm, the flow rate of 1.0mL · min-1. Results: The linear range of cholesterol concentration was 51.15-111.5 μg · mL-1 (r = 0.9999). The average recovery was 98.75% (RSD = 0.94%). Conclusion: The established method is accurate and reliable, which can effectively control the quality of Ganding Ding raw materials.