复方氨溴索氯雷他定胶囊溶出度测定方法的研究

Determination of dissolution for ambroxol hydrochloride and loratadine compound capsules

目的:建立HPLC法测定复方氨溴索氯雷他定胶囊中盐酸氨溴索和氯雷他定的溶出度方法。方法:以0.1mol/L盐酸溶液1 000 ml为溶出介质,转速为50 r/mi n,取样时间为20 min,以溶出度第二法(桨法)测定。采用KromasilC18(50 mm×4.6 mm,5μm)色谱柱,磷酸盐缓冲液-乙腈(1∶1)的流动相,检测波长为247 nm,柱温为室温。结果:盐酸氨溴索的线性方程Y=1.4×106X-2.298×104(r=0.999 7),在6～36 mg/L浓度范围内线性良好,平均回收率为100.63%,RSD为0.7%;氯雷他定线性方程:Y=2.2×106X-9 278.9(r=0.999 9),在1～6 mg/L浓度范围内线性关系均良好,平均回收率为99.60%,RSD为1.8%。结论:本方法准确可靠,适用于该制剂的质量控制。

Objective：To establish an HPLC method for determination of dissolution for ambroxol hydrochloride and loratadine compound capsule.Methods：1 000 ml of 0.1 mol/L hydrochloric acid solution was used as a solvent with rotating speed of a paddle at 50 r /min.The sampling time was 20 min.The samples was quantitatively analyzed by an HPLC method,in which a kromasil C18 analytical column was used as stationary phase and a mix of phosphate buffer-acetonitrile（1∶1） as mobile phase.The detection wavelength was at 247 nm.Results：The regression equation of ambroxol hydrochloride was as Y=1.4×106 X-2.298×104（r=0.999 7）.The average recovery of ambroxol hydrochloride was 100.63%,with RSD of 0.70%.The regression equation of loratadine was as Y=2.2×106 X-9 278.9（r=0.999 9）.The average recovery of loratadine was 99.60%,with RSD of 1.8%.Conclusion： The method is accurate and suitable for dissolution determination for ambroxol hydrochloride and loratadine compound capsule.