高效液相色谱法同时测定复方倍他米松注射液两主成分含量  

Simultaneous Determination of Two Main Components in Compound Betamethasone Injection by HPLC

作　　者：沈丹丹 肖波[3] 姜学美 张涛 

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121 [2]重庆市药物过程与质量控制工程技术研究中心,重庆401121 [3]重庆医药工业研究院有限责任公司,重庆400061 [4]福安药业集团重庆礼邦药物开发有限公司,重庆401121

出　　处：《中国药业》2017年第21期25-29,共5页China Pharmaceuticals

摘　　要：目的建立同时测定复方倍他米松注射液中倍他米松磷酸钠及二丙酸倍他米松含量的高效液相色谱(HPLC)法。方法流动相为甲醇-乙腈-0.01 mol/L磷酸二氢铵(取磷酸二氢铵1.15 g,用水1 000 mL溶解后,加20%四丁基氢氧化铵28 mL,用磷酸调pH至7.0)溶液(34∶30∶36),检测波长为242 nm,柱温为35℃,流速为1.0 mL/min,进样量为10μL。结果倍他米松磷酸钠及二丙酸倍他米松相邻色谱峰之间的分离度大于1.5,质量浓度分别在0.052 6~1.316 0 g/L(r=0.999 9)和0.115 2~2.879 7 g/L(r=1.000 0)范围内与峰面积线性关系良好,平均回收率分别为99.54%和99.78%,RSD分别为0.94%和0.70%(n=9);倍他米松磷酸钠在光照条件下含量急剧下降。结论该方法可同时测定复方倍他米松注射液中倍他米松磷酸钠、二丙酸倍他米松的含量,可用于其质量控制。Objective To establish an HPLC method for simultaneous determination of betamethasone sodium phosphate and betamethasone dipropionate in Compound Betamethasone Injection. Methods The mobile phase was methanol-acetonitrile-0. 01 mol/L ammonium dihydrogen phosphate（ ammonium dihydrogen phosphate 1. 15 g was dissolved in 1 000 mL water, 28 mL 20% tetrabutylammonium hydroxide（ TBAH） was added,and the pH was adjusted to 7 with phosphoric acid）（ 34 ∶ 30 ∶ 36）,the detection wavelength was 242 nm,the column temperature was 35 ℃,the flow rate was 1. 0 mL/min and the sample size was 10 μL. Results The resolution among the adjacent chromatographic peaks of betamethasone sodium phosphate and betamethasone dipropionate was greater than 1. 5. Betamethasone sodium phosphate and betamethasone dipropionate in the ranges of 0. 052 6-1. 316 0 g/L（ r = 0. 999 9）, 0. 115 2-2. 879 7 g/L（ r = 1. 000 0） showed a good linearity. The average recovery rates were 99. 54%, 99. 78%, RSDs were 0. 94%, 0. 70%（ n = 9）. The content of betamethasone sodium phosphate decreased sharply in the light conditions. Conclusion The method can simultaneously determine the content of betamethasone sodium phosphate and betamethasone dipropionate in Compound Betamethasone Injection, which can be used for the quality control of the products.

关 键 词：复方倍他米松注射液 倍他米松磷酸钠 二丙酸倍他米松 含量 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]