HPLC法测定注射用倍他米松磷酸钠的含量和有关物质  

Determination of betamethasone sodium phosphate for injection and its related substances by HPLC

作　　者：徐岩[1] 

机构地区：[1]天津市儿童医院,天津300074

出　　处：《天津药学》2015年第5期12-14,共3页Tianjin Pharmacy

摘　　要：目的：建立HPLC法测定不同厂家注射用倍他米松磷酸钠的有关物质及含量,考查了2个规格6批产品的质量差异。方法：采用反相高效液相色谱法,色谱柱为C18柱（250 mm×4.6 mm,5μm）,流动相为甲醇-0.05 mol/L磷酸二氢钾溶液（1∶1）,流速为1.0 ml/min,检测波长为254 nm和241 nm。结果：倍他米松磷酸钠在0.66～66.0μg/ml（0.05%～5.0%）的浓度范围内与其峰面积呈良好线性关系（r=0.999 9）,倍他米松在0.5～50.0μg/ml（0.05%～5.0%）的浓度范围内与其峰面积呈良好线性关系（r=0.999 9）。平均回收率为100.2%,RSD为0.4%（n=9）。结论：本方法结果准确,重复性好,能有效控制产品质量。Objective： To establish an HPLC method for determination of the related substances and the content in betamethasone sodium phosphate for injection and evaluate the quality variations. Methods： An RP- HPLC system,including a C18column（ 250 mm × 4. 6 mm,5 μm） and the solution of methanol- 0. 05 mol / L potassium dihydrogen phosphate（ 1 ∶ 1）（ mobile phase）,was used. The flow rate of mobile phase was 1. 0 ml / min,and detecting wavelengths were 254 nm and 241 nm. Results： The assay displayed a good linearity of betamethasone sodium phosphate over the concentration range of 0. 66 ～ 66. 0 μg / ml（ r = 0. 999 9）,and a good linearity of betamethasone over the concentration range of 0. 5 ～ 50. 0 μg / ml（ r = 0. 999 9）. The average recoveries were100. 2% and RSD was 0. 4%（ n = 9）. Conclusion： The established method is accurate and simple,and is a guarantee for quality control of betamethasone sodium phosphate for injection.

关 键 词：注射用倍他米松磷酸钠 有关物质 质量控制 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]