高效液相色谱法测定利塞膦酸钠片的含量

Study on Chromatographic Condition in Assay of Sodium Risedronate Tablets by HPLC

目的 采用反相高效液相色谱法建立利塞膦酸钠片剂的含量测定方法。方法 色谱柱为 Shi-madzu CLC-ODS柱 ,流动相为甲醇 -水 (含 5 mmol/ L磷酸二氢铵 ,2 mmol/ L四丁基溴化铵 ,1 .5 mmol/ L乙二胺四乙酸二钠 ,用氢氧化钠溶液调节 p H至 7.2 ) (2 5∶ 75 ,v/ v) ,检测波长为 2 62 nm,流速为 1 ml/ min。结果 辅料及中间体对样品测定不产生干扰 ,利塞膦酸钠在浓度 2 .0～ 64 .0 μg/ ml与峰面积呈良好线性关系 ,平均回收率为 99.76% (n=9) ,RSD为 0 .4 5 (n=6)。

AIM The purpose is to develop RP-HPLC method for the assay o f sodium risedro nate tablets. METHODS Separation was performed on a Shimadzu CLC -ODS column. The mobil e phase consisted of methanol-5 mmol/L NH 4H 2PO 4, 2 mmol/L TBA-Br and 1.5 mmol/L EDTA-2Na buffer adjusted to pH 7.2 with NaOH solution (25∶75,v/v). The flow ra te was 1 ml/min. The UV detection was set at 262 nm. RESULTS The ex cipient and in termediate compounds did not interfere with sodium risedronate. A good lineari ty was found over the concentration range of 2.0 to 64.0 μg/ml. The recovery wa s 99.76%(n=9). The RSD for repeatability was 0 45% (n=6). CONC LUSION The meth od was simple and accurate. It could be used for the assay of sodium risedronate tablets.