毛细管区带电泳法测定盐酸雷尼替丁注射液的含量和有关物质  

Simultaneous determination of content and related substances in ranitidine hydrochloride injection by capillary zone electrophoresis

作　　者：杨直[1] 林丽琴[1] 汪霞 金朦娜 

机构地区：[1]杭州市食品药品检验研究院,杭州310022

出　　处：《药物分析杂志》2017年第11期2025-2030,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立毛细管区带电泳法测定盐酸雷尼替丁注射液的含量和有关物质。方法:采用扩展光程(鼓泡检测池)未涂渍熔融石英毛细管(有效长度:56 cm;内径:75μm;鼓泡因子:2.7);以柠檬酸三钠-柠檬酸缓冲液(30 mmol·L^(-1),p H 5.5)为运行缓冲液;压力进样:3.0 k Pa(10 s);操作电压:30 k V;检测波长:230nm;毛细管柱温:25℃。结果:雷尼替丁在1.015~203.1μg·m L^(-1)(r=0.999 9,n=7)范围内线性关系良好,准确度为99.3%(RSD=3.3%;n=9),检出限为0.338 mg·m L^(-1),重复性和日间精密度分别为1.6%和1.0%。雷尼替丁与主要的杂质均能有效分离。主要杂质雷尼替丁有关物质A、B、C分别在0.789 3~157.9μg·m L^(-1)(r=0.999 9,n=8)、1.003~200.6μg·m L^(-1)(r=0.999 8,n=8)、1.005~201.0μg·m L^(-1)(r=0.999 7,n=8)范围内线性关系良好,相对校正因子分别为1.219、1.179、1.278,检出限分别为0.395μg·m L^(-1)、0.502μg·m L^(-1)、0.502μg·m L^(-1),准确度分别为113.2%(RSD=2.9%;n=9)、107.5%(RSD=3.0%;n=9)、101.1%(RSD=2.8%;n=9)。结论:该方法具有简便、准确、经济的特点,可用于盐酸雷尼替丁注射液的含量和有关物质测定。Objective： To establish a capillary zone electrophoresis method for simultaneous determination of content and related substances in ranitidine hydrochloride injection. Methods： The analysis was performed on an extended light path （ Bubble Cell ） bare fused-silica capillaries of 75 μm × 56 cm （ 2.7 of bubble factor ） with 30 mmol ·L-1 tri-sodium citrate-citric acid buffer solution （ pH 5.5 ）. The pressure injection was 3.0 kPa for 3 s, the separation voltage was 30 kV and the wavelength of detection was 230 nm. The column temperature was at 25 ℃. Results： The linearity of the calibration curves for ranitidine was 1.015 μg· mL-1-203.1 μg· mL-1 （ r=0.999 9, n=7 ） with 99.3% （ RSD=3.3%, n=9 ） of accuracy. The LOD of ranitidine was 0.338 μg· mL-1, the RSD of the repeatability and the intermediate precision were 1.6% and 1.0%, respectively. Ranitidine and major impurities could be separated well. The linearity of the calibration curves for Ranitidine Related Compound A, Related Compound B and Related Compound C was 0.789 3 μg· mL-1-157.9 μg· mL-1 （ r=0.999 9, n=8 ）, 1.003 μg· mL-1-200.6 μg·mL-1 （ r=0.999 8, n=8 ）, 1.005 μg· mL-1-201.0μg· mL-1 （ r=0.999 7, n=8 ）, respectively. The relative correcting factor of the ranitidine related compound A, related compound B and related compound C was 1.219, 1.179 and 1.278, respectively, while LOD was found to be 0.395 mg· mL-1, 0.502 mg· mL-1, 0.502 mg· mL-1, and the RSD of average recovery was 113.2% （ RSD=2.9%; n=9 ）, 107.5% （ RSD=3.0% ; n=9 ）, 101.1% （ RSD=2.8%; n=9 ） , respectively. Conclution： The method is simple, accurate, economic and suitable for the determination of content and related substances in ranitidine hydrochloride injection.

关 键 词：组胺H2受体阻断剂 盐酸雷尼替丁 含量测定 杂质 雷尼替丁杂质A 雷尼替丁杂质B 雷尼替 

分 类 号：R917[医药卫生—药物分析学]