摘要
目的建立缬沙坦氨氯地平片有关物质含量的测定方法。方法采用高效液相色谱法,Agilent1220高效液相,(Eclipse plus,250 mm×4.6 mm,5μm)色谱柱,以磷酸盐缓冲液(取三乙胺10 m L加水至1 000 m L,用磷酸调节p H值至2.8)为流动相A,以甲醇—乙腈(70∶30)为流动相B,进行线性梯度洗脱,流速为1.0 m L·min-1,检测波长为237 nm。结果氨氯地平与杂质D分离度为14.44,缬沙坦与杂质B的分离度为9.46,且各物质之间有较好的分离;空白辅料对有关物质测定无干扰,专属性良好;强制降解试验中,杂质可与主峰完全分离。结论该方法结果准确,重复性好,可靠性强,可用于测定缬沙坦氨氯地平片中的有关物质。
Objective Aimed to establish an analytical method for related substances of valsartan Amlodipine tablets. Methods The sample was determined by HPLC （Agilent1220）. The analysis was performed on Eclipse plus Clscolumn （250 mm×4.6 ram, 5 μm） with the detection wavelength at 237 nm. Using phosphate buffer （ 10 ml triethylamine volumetric to 1 000 mL,adjusted to pH 2.8 with phosphoric acid） as mobile phase A, methanol - acetonitrile （70：30） as mobile phase B, and linear gradient, mobile phase was initi- ated at a flow rate of 1.0 mL · min -1. Results The resolution of amlodipine and impuritie D was 14.44;the resolution of amlodipine and impuritie B was 9.46, and there was good resolution between each substance. Conclusions This method is accurate, reproduci- ble and reliable, which can be used to determine the related substances of valsartan Amlodipine tablets.
出处
《安徽医药》
CAS
2016年第4期651-655,共5页
Anhui Medical and Pharmaceutical Journal
