RP-HPLC法测定马来酸咪达唑仑片的含量及有关物质  

Determination of Content and Related Substances of Midazolam Malerte Tablets by RP-HPLC

作　　者：黄朝瑜[1] 蔡美明[1] 樊夏雷[1] 

机构地区：[1]江苏省食品药品检验所,江苏南京210008

出　　处：《药学进展》2010年第3期130-133,共4页Progress in Pharmaceutical Sciences

基　　金："十一五"国家科技支撑计划重点项目(2008BAI55B00-001)

摘　　要：目的:建立RP-HPLC法,测定马来酸咪达唑仑片含量及有关物质。方法:采用C18柱(250 mm×4.6 mm,5μm),甲醇-醋酸盐缓冲液(0.1 mol.L-1冰醋酸,加0.1 mo.lL-1氢氧化钠溶液调pH至3.5)(60∶40)为流动相,流速为1.0 mL.min-1,检测波长为220 nm,柱温为30℃,进样量为10μL。结果:咪达唑仑与已知杂质分离度大于3.0,马来酸咪达唑仑在0.01～1.00 g.L-1范围内线性关系良好(r=0.999 9),总平均回收率为99.49%(n=9)。结论:该法简便、灵敏,结果准确、可靠,可用于马来酸咪达唑仑片含量测定及有关物质检查。Objective： To establish a RP-HPLC method for the determination of the content and related substances of midazolam malerte tablets. Methods： A C18 column （250 mm × 4.6 mm, 5 μm） at 30 ℃ and methanol-acetate buffer （ adjusted to pH 3.5 with 0.1 mol·L^-1 NaOH） （60： 40） as mobile phase at a flow rate of 1.0 mL·min^-1 were used with a detecting wavelength of 220 nm and an injection volume of 10 μL. Results：The resolution between midazolam malerte and the known impurity was more than 3.0. The calibration curve was linear in the range of 0. 01 - 1.00 g·L^-1 （ r = 0. 999 9） for midazolam malerte. The total average recovery was 99.49% （ n = 9）. Conclusion： The method is simple, sensitive, accurate and reliable for the determination of the content and related substances of midazolam malerte tablets.

关 键 词：马来酸咪达唑仑片 反相高效液相色谱 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]