HPLC-UV法测定鱼油脂肪乳注射液中L-抗坏血酸棕榈酸酯  

Determination of L-ascorbgyl palmitate in Fish Oil Fat Emulsion by HPLC-UV

作　　者：蔡文坚 谢春燕 柳文俊 钟棱 曾少群 岳峰 CAI Wenjian;XIE Chunyan;LIU Wenjun;ZHONG Leng;ZENG Shaoqun;YUE Feng(Guangdong Jiabo Pharmaceutical Co.,Ltd.,Qingyuan 511517,China)

机构地区：[1]广东嘉博制药有限公司,广东清远511517

出　　处：《广东药科大学学报》2020年第5期639-642,共4页Journal of Guangdong Pharmaceutical University

摘　　要：目的建立测定鱼油脂肪乳注射液中L-抗坏血酸棕榈酸酯质量分数的HPLC法。方法采用十八烷基硅烷键合硅胶为填充剂(100 mm×2.1 mm,5μm);以0.1%KH 2PO 4溶液-甲醇(体积比25∶75,用H 3PO 3调节pH值至4.0)为流动相A,以四氢呋喃-水(体积比45∶55)为流动相B,进行梯度洗脱;流速:0.7 mL/min;检测波长:265 nm;柱温:40℃。结果L-抗坏血酸棕榈酸酯的质量浓度在0.05~0.5 mg/mL范围内与峰面积呈良好线性关系(r=0.9997);对照品和供试品重复性试验的RSD值分别为0.2%和1.0%,回收率为99.5%,供试品溶液放置8 h稳定。结论建立的方法操作简便、准确可靠,可作为鱼油脂肪乳注射液中L-抗坏血酸棕榈酸酯质量分数的测定方法。Objective To establish a method for the determination of L-ascorbgyl palmitate in Fish Oil Fat Emulsion by HPLC.Methods HPLC was adopted on an ODS-C18 column(100 mm×2.1 mm,5μm),with 0.1%potassium dihydrogen phosphate solution-methanol(25∶75,adjust pH to 4.0 with phosphoric acid)as mobile phase A and tetrahydrofuran-water(45∶55)as mobile phase B by gradient elution.The flow rate was 0.7 mL/min,and the column temperature was set at 40℃with the detection wavelength of 265 nm.Results The standard curve was in good linearity in the range of 0.05-0.5 mg/mL(r=0.9997).The repeatability of reference substance and product was 0.2%and 1.0%.The average recovery was 99.5%.The test solution was stable for 8 h.Conclusion The method is simple and suitable,with good accuracy,which can be used for determination of L-ascorbgyl palmitate in Fish Oil Fat Emulsion.

关 键 词：鱼油脂肪乳注射液 L-抗坏血酸棕榈酸酯 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]