HPLC-ELSD法测定因卡膦酸二钠有关物质的研究  

Study on determination of related substances in Incadronate Disodium by HPLC-ELSD

作　　者：石玮[1] 石秀伟[1] 

机构地区：[1]天津市轩宏医药技术有限公司,天津300384

出　　处：《海峡药学》2010年第6期55-57,共3页Strait Pharmaceutical Journal

摘　　要：目的建立测定因卡膦酸二钠有关物质的HPLC-ELSD方法。方法采用C18Kromasil柱(250 mm×4.6 mm,5μm);流动相:含10mmol.L-1正戊胺的5 mmol.L-1醋酸铵溶液(用醋酸调节pH=7.0)-甲醇(97∶3)。流速为1.0 mL.min-1,蒸发光检测器参数:漂移管温度:113℃,载气流量:3.1 L.min-1。柱温为30℃。结果在本色谱条件下,磷酸及亚磷酸与因卡膦酸二钠能良好的分离,破坏后分解产物能与因卡膦酸二钠较好的分离,溶液浓度在5μg.mL-1～20μg.mL-1范围内有较好的线性及精密度。结论测定方法简便、准确、灵敏度高,方法可靠,可用于因卡膦酸二钠的有关物质测定。OBJECTIVE To establish an HPLC-ELSD method for determination of related substances in Incadronate Disodium.METHODS The separation was performed with a C18 Kromasil column（250 mm×4.6 mm,5 μm）at 30 ℃;The mobile phase was a mixture of methanol（3%） and 5 mmol·L-1 ammonium acetate buffer（97%） containing 10 mmol·L-1 amylamine,and was adjusted to pH 7.0 with acetic acid and delivered at a flow-rate of 1.0 mL·min-1.The drift tube temperature of ELSD detection was 113℃,and the gas flow was 3.1 L·min-1.RESULTS In this chromatogram system,phosphoric acid and phosphorous acid were completely separated with Incadronate Disodium,cleavage products were satisfactorily isolated with Incadronate Disodium.In the range of 5 μg·mL-1～20 μg·mL-1,the linear and precision was perfect.CONCLUSION This method is simple,accurate,sensitive and applicable for determination related substances of Incadronate Disodium.

关 键 词：因卡膦酸二钠 高效液相色谱-蒸发光散射法 有关物质 

分 类 号：R927.2[医药卫生—药学]