复方碳酸钙制剂中维生素D_(3)含量测定方法的研究  

Study on the Determination of Vitamin D_(3)in Calcium Carbonate Compound Preparation

作　　者：周临[1] 罗荣[1] 陈梅荣[1] 陈卫[1] ZHOU Lin;LUO Rong;CHEN Meirong;CHEN Wei(Jiangxi Medical Device Testing Center(Jiangxi Provincial Institute of Medicine),Nanchang Jiangxi 330029,China)

机构地区：[1]江西省医疗器械检测中心(江西省药物研究所),江西南昌330029

出　　处：《药品评价》2022年第17期1043-1046,共4页Drug Evaluation

摘　　要：目的:建立高效液相色谱法(HPLC)测定碳酸钙和维生素D的复方制剂中维生素D_(3)的含量。方法:采用Agilent XDB-C18色谱柱(150 mm×4.6 mm,5μm),以甲醇-水(95∶5)为流动相,流速为2.0 mL/min,检测波长265 nm,柱温25℃。结果:维生素D_(3)在0.051μg/mL~6.336μg/mL的浓度范围内线性良好,相关系数r=1.0000,平均回收率为99.50%,RSD为0.76%(n=9)。结论:该方法稳定、准确、快速,可作为碳酸钙和维生素D的复方制剂中维生素D_(3)的含量测定方法。Objective:To establish a high-performance liquid chromatography(HPLC)method for the determination of vitamin Din calcium carbonate and vitamin D_(3) compound.Methods:Agilent XDB-C18 column(150 mm×4.6 mm,5μm)was used with methanol-water(95∶5)as mobile phase,the flow rate was 2.0 mL/min,detection wavelength was 265 nm,column temperature was 25℃.Results:The linear range of vitamin Dwas from 0.051μg/mL to 6.336μg/mL,r=1.0000.The average recovery of vitamin D_(3) was 99.50%and the RSD was 0.76%(n=9).Conclusion:The method is stable,accurate and rapid.It can be used for the determination of vitamin Din compound preparation of calcium carbonate and vitamin D_(3).

关 键 词：维生素D_(3) 含量测定 复方制剂 碳酸钙 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]