高效液相色谱法测定盐酸坦索罗辛及其缓释胶囊的含量和有关物质

HPLC determination of content and related substances of tamsulosin hydrochloride and its sustained release capsules

目的:建立一种高效液相色谱法同时测定盐酸坦索罗辛缓释胶囊含量及有关物质。方法:采用 ODS 柱(150 mm×4.6mm,5 μm),以甲醇-0.2 mmol·L^(-1) Na_2HPO_4-KH_2PO_4(pH 5.9)(6:4)为流动相,柃测波长275 nm,流速1.0 mL·min^(-1).柱温30℃。结果:盐酸坦索罗辛在5.06～130.65μg·mL^(-1)(r=0.9995)、R 型手性胺在5.26～132.60 μg·mL^(-1)(r=0.9993)、2-(2-乙氧基苯氧基)溴乙烷在5.06～130.65 μg·mL^(-1)(r=0.9999)范围内线性关系良好,平均回收率分别为100.8%,105.1%,103.5%。结论:该方法简单,快速,专属性强,适于测定盐酸坦索罗辛原料药和缓释胶囊中盐酸坦索罗辛含量及有关物质。

Objective：To establish an HPLC method for the determination of content of tamsulosin hydrochloride and its sustained release capsules and related substances. Methods ：The analysis was carried out with ODS （150 mm ×4. 6 mm,5 μm） column,using methanol -0. 2 mmol · L-1 Na2HPO4 -KH2PQ（pH 5.9） （6：4） as the mobile phase. The flow rate was 1.0 mL · min- 1, the detection wavelength was set at 275 nm and the column temperature was 30 ℃. Results： The calibration curve for tamsulosin hydrochloride, （ R ） - 5 - （ 2 - aminopropyl） - 2 - me- thoxybenzenesulfonamide and 2 - （2 -ethoxyphenoxy） ethyl bromide were linear in the range of 5.06 -130.65μg · mL-1 （r =0. 9995） ,5.26 - 132.60 μg · mL-1（r =0. 9993） and 5.06 - 130. 65 μg · mL-1 （r =0. 9999） ,the average recoveries were 100. 8%, 105.1% and 103.5 %, respectively. Conclusion：The method is proved to be spe- cific, accurate and convenient. The proposed RP - HPLC method can be used for the determination of tamsulosin hydrochloride and its sustained release capsules and related substances.